Stemedica News

Stemedica Completes Pre-IND Meeting with the FDA for Ischemic Tolerant Neural Stem Cells (itNSC)

2012-01-24T11:30:00.000-08:00

(Source: January 24 2012; Stemedica Cell Technologies, Inc.)

The proposed initial clinical trial will be a Phase I/IIa for safety and dose escalation using ischemic tolerant adult allogeneic itNSCs administered via lumbar puncture to patients with spinal cord injury and paralysis. The proposed trial will take place at medical centers within the United States.

“We appreciate the guidance and help we obtained in our FDA discussions. We are using this information to fine-tune our IND submission,” said Lev Verkh, Ph.D., Chief Regulatory & Clinical Development Officer at Stemedica.

Nikolai Tankovich, M.D., Ph.D., Stemedica’s President and Chief Medical Officer pointed out the significance of Stemedica’s itNSCs and their relevance to the research and translational medicine communities, “Stemedica has been able to achieve a number of breakthroughs in the manufacture of neural stem cells. The first involves differentiation; more than 80 percent of our stem cells differentiate into functional neurons. We have also proven in vivo that our itNSCs not only migrate, but also engraft and then demonstrate action potential. In other words, they are capable of carrying critical electrical signals.”

Stemedica’s itNSCs are derived from a single tissue source and expanded under environmentally deprived conditions. Expansion under these conditions enables the cells to function more effectively in areas of tissue damage. Using the Company’s proprietary expansion techniques, an estimated 150,000 treatment doses of 100 million stem cells per dose can be derived from this single tissue source. Furthermore Stemedica itNSCs undergo only four passages for the final product, eliminating the problems associated with contamination and mutations. In order to achieve adequate number of cells for clinical applications, most companies must complete 10 or more passages. The Company has a filed a patent application for its ischemic tolerant neural stem cells.

Maynard Howe, Ph.D., Chief Executive Officer of Stemedica noted that, “Stemedica is the only company that owns the entire manufacturing process through commercialization for multiple cells, including ischemic tolerant mescenchymal and neural stem cells. We manufacture our cells under government license and set the highest standards for purity, safety, and batch to batch consistency.” The itNSCs are manufactured in licensed facilities in San Diego, California and in Lausanne, Switzerland.

The Company’s cGMP produced stem cells are available for sale to researchers and hospitals conducting clinical trials.

About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies, Inc. is a specialty biopharmaceutical company that is committed to the development and manufacturing of best-in-class adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and human clinical trials. The Company is currently conducting clinical trials for stroke under US IND using ischemic tolerant mesenchymal (itMSC) stem cells. Regulatory pathways for spinal cord injury, diabetic retinopathy, acute myocardial infarct, acute respiratory distress syndrome and wound repair are also underway. Stemedica is headquartered in San Diego, California.

Media Contact for Stemedica: Dave McGuigan at dmcguigan@stemedica.com

Stemedica Perspective On Geron's Departure From The Stem Cell Industry

2011-11-23T01:31:00.000-08:00

(November 23 2011; Stemedica Cell Technologies, Inc.)

The Geron Corporation, a biopharmaceutical company that was developing cell therapy products from differentiated human embryonic stem cells for multiple indications, recently announced that they have decided to exit the stem cell industry citing financial reasons and what is perceived to be a very long regulatory pathway for its embryonic stem cell technology

There are many opinions on how this news will impact the stem cell industry. Please read our response below.

Geron Exits Stem Cell Industry: Stemedica Response

Stemedica Neural Stem Cells Successful in Preclinical Study of Spinal Cord Injury

2011-11-14T03:00:00.000-08:00

San Diego, CA (Source: November 14 2011; Stemedica Cell Technologies, Inc.)

Transplanted neural stem cells (NSCs) developed by Stemedica Cell Technologies, Inc., a leader in adult allogeneic stem cell manufacturing, research and development were successful in treating rats with spinal cord injury (SCI). The research conducted by Ivan Cheng, M.D., Assistant Professor in the Department of Orthopedic Surgery, Stanford University School of Medicine, was presented at the North American Spine Society Annual Meeting in Chicago, IL on November 2, 2011. Dr. Cheng’s paper was entitled Functional Assessment of Acute Local Versus Distal Transplantation of Human Neural Stem Cells Following Spinal Cord Injury. The data represent a significant finding in the field of spinal cord research.

Twenty-four subjects underwent a controlled injury at the T10 (thoracic) level, rendering them paraplegic. Experimental subjects received either an injection of Stemedica’s ischemic tolerant human NSCs adjacent to the site of injury (local injection), or an intrathecal injection (lumbar puncture) of NSCs distal to the site of injury. Control subjects received an injection of control media alone either local or distal to the site of injury. Subjects were assessed following injury and then weekly for six weeks.

According to Dr. Cheng, "The acute transplantation of NSCs into the rat’s injured spinal cord lead to significant functional recovery. This occurred whether the cells were injected either locally or distally. This preclinical research holds promise for patients in that we may be able to inject Stemedica NSCs through a traditional lumbar puncture in the acute phase after their injury."

Stemedica's ischemic tolerant neural stem cells were developed by Alex Kharazi, M.D., Ph.D., Chief Technology Officer at Stemedica and were made available to leading medical institutions for preclinical research. Dr. Kharazi notes that "Dr. Cheng's data in rats support our internal research. We have successfully transplanted NCSs into chicken embryonic brain and demonstrated that our NSCs engraft, migrate and differentiate into a variety of neural and glial cells."

An Investigational New Drug (IND) application for NSC use in human clinical trials is currently being prepared for submission to the Food and Drug Administration for initiation of clinical trials in Q1, 2012. The NSCs are the second product to be released by the San Diego based company. Ischemic tolerant mesenchymal stem cells are currently in a Phase I/IIa clinical trial for ischemic stroke at the University of California, San Diego School of Medicine.

Nikolai Tankovich, M.D., Ph.D., Stemedica's President and Chief Medical Officer, points to the significance of these findings, "This basic science research is encouraging for the more than 250,000 Americans who suffer from spinal cord injury, and the 11,000 who join their ranks each year. We look forward to the day when effective treatment for spinal cord injury can limit and help reverse the damage and suffering that these patients endure."

Maynard Howe, Ph.D., CEO of Stemedica noted that, "We anticipate continuing our collaboration with the researchers at Stanford University to advance a clinical trial path for patients with this debilitating condition."

About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies, Inc. is a specialty bio-pharmaceutical company committed to the manufacturing and development of best-in-class allogeneic adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and clinical (human) trials. The company is a government licensed manufacturer of clinical grade stem cells and is approved by the FDA for its clinical trials for ischemic stroke. Stemedica is currently developing regulatory pathways for a number of medical indications using adult allogeneic stem cells. The Company is headquartered in San Diego, California.

Media Contact for Stemedica: Dave McGuigan at dmcguigan@stemedica.com

Stemedica Completed Enrollment In First Cohort Of Patients With Ischemic Stroke Utilizing Allogeneic Mesenchymal Stem Cells

2011-10-21T01:15:00.000-07:00

Stemedica Cell Technologies, Inc., a leader in adult allogeneic stem cell manufacturing, research and development, announced today that its specially formulated ischemic adult allogeneic mesenchymal stem cells have been successfully used to treat the first cohort of patients in an ischemic stroke study conducted at the University of California, San Diego (UCSD). A total of 35 patients will be enrolled in the clinical trial entitled: “A Phase I/II, Multi-Center, Open-Label Study to Assess the Safety, Tolerability and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Mesenchymal Bone Marrow Cells to Subjects with Ischemic Stroke.”

Lev Verkh, PhD, Stemedica’s Chief Regulatory and Clinical Development Officer, commented: “All patients in the first cohort received an initial dose of adult allogeneic stem cells and no product related adverse events were reported. An Independent Data Safety Monitoring Board (DSMB) reviewed the safety data for the subjects including adverse events, laboratory data and vital signs and based on that review, the DSMB unanimously voted for the study to proceed to the next dose.”

The Principle Investigator Michael Levy, MD, PhD, FACS, Chief of Pediatric Neurosurgery at Children's Hospital San Diego (CHSD) and Professor of Neurological Surgery at the University of California, San Diego (UCSD) commented that “he is pleased with the safety profile demonstrated in this initial phase of the study and is looking forward to completing Cohorts 2 and 3 given the promising results to date.”

Patients in this study have significant functional or neurologic impairment that confines them to a wheelchair or requires home nursing care or assistance with the general activities of daily living and have received the ischemic stroke diagnosis at least six months prior to enrollment in this study.

Information on enrolling in the study can be found at http://clinicaltrials.gov/ct2/results?term=stemedica.

More than 800,000 Americans suffer a stroke annually and according to the American Heart Association, stroke is the fourth leading cause of death - costing an estimated $73.7 billion in 2010 for stroke-related medical costs and disability.

About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies, Inc. is a specialty bio-pharmaceutical company that is committed to the manufacturing and development of best-in-class allogeneic adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and clinical (human) trials. The company is a government licensed manufacturer of clinical grade stem cells and is approved by the FDA for its clinical trial for ischemic stroke. Stemedica is currently developing regulatory pathways for a number of medical indications using adult allogeneic stem cells. The Company is headquartered in San Diego, California.

Media Contact for Stemedica: Dave McGuigan at dmcguigan@stemedica.com

Stem Cell Partnership In Lebanon Announced

2011-06-20T00:46:00.000-07:00

Amni BioScience, SAL (“AMNI”) announced today the formal signing of a long-term agreement with Clinique Du Levant Société Médicale SAL (“LEVANT”) in Beirut, Lebanon. This agreement will initiate a wide array of therapies involving the use of adult stem cell products as manufactured by Stemedica Cell Technologies under FDA (United States Federal Drug Administration) approval.

In order to maximize the rapidly expanding research and clinical application opportunities available within the fields of restorative and regenerative medicine, AMNI and LEVANT plan on playing a critical role in the full evolution of the most advanced regenerative-based therapies and services. “We’re honored to be working with a facility with the kind of outstanding leadership as LEVANT”, said Amni BioScience President Mr. Sam Alkhass. “Together, we plan on becoming a world leader in the fields of restorative and regenerative medicine.”

The agreement between AMNI and LEVANT calls for the pro-active implementation of clinical trials using allogeneic adult stem cells as manufactured by Stemedica Cell Technologies, Inc., San Diego, California (“STEMEDICA”) as well as their wholly-owned, Swiss-based subsidiary, Stemedica International. Stemedica is licensed to manufacture allogeneic adult stem cells under cGMP manufacturing practices and is regarded as a world leader in the development and manufacture of allogeneic adult stem cells. “We’re excited about the relationship that our exclusive Middle East Distributor, Amni, has agreed to with LEVANT”, said Dr. Nikolai Tankovich, Chairman of Stemedica International and President, Chief Medical Officer of Stemedica International’s parent firm, Stemedica Cell Technologies, Inc. “We look forward to developing a long and mutually-beneficial working relationship between Stemedica International, which services our Middle East operations, and partnership with LEVANT.”

Stemedica’s product line will be imported into Lebanon by Benta Pharmaceutical, (“BENTA”) the Nation’s leading Pharmaceutical Manufacturing Company. “We’re pleased to be joining Amni BioScience and Stemedica as we work together to bring the regenerative powers of allogeneic adult stem cells to Lebanon and the Middle East”, said Mr. Bernard Tannoury, Chairman of Benta. “Together we will bring the safest and most clinically advanced allogeneic adult stem cells to the region for the betterment of patients and the economy alike.”

Once all importation requirements have been met, Amni BioScience will work closely with the medial leadership of LEVANT to implement a “Clinical Trial to Commercial Pathway” strategy for one or more medical indications. According to AMNI’s Chief Medical Officer, Dr. Jean Pierre SAAB, “We’re working closely with the Ministry of Health in Lebanon, Scientific Societies and Lebanese Order of Physicians, to establish regulatory guidelines that protect patients and create the highest levels of safety and efficacy. We’re committed to helping establish “The Gold Standard” in safety and clinical trial advancements of stem cells here in Lebanon and throughout the Middle East.”

Clinique Du Levant Société Médicale SAL is regarded as one of the most prestigious medical facilities in the Middle East and is recognized for its advanced medical treatment in numerous medical categories. “We’re delighted to be working with Amni BioScience leadership and look forward to building our relationship and service offerings into the regional leader for restorative and regenerative health care. We believe our relationship with the stem cell movement is an excellent addition to the many advanced and basic medical offerings of our facility”, said Dr.Antoine Maalouf, Chairman of LEVANT.

About Amni BioScience SAL
Our vision is to build Amni into a medical powerhouse in the region through the promotion of the most advanced medical services and technologies available in the Middle East. We are bringing this vision into reality through a comprehensive series of representation, ownership and acquisition positions with a select number of targeted corporate partners and properties.
http://www.amnibioscience.com

About Clinique Du Levant Société Médicale SAL
The mission of Clinique Du Levant Société Médicale is to provide the highest quality of care and service for all people, while preserving quality of life, by attracting and supporting physicians of the highest character and greatest skill. LEVANT provides world class medical care, continual education, through highly specialized physicians, and dedicated staff. LEVANT is located in Beirut, Lebanon.
http://www.lacliniquedulevant.com

About Stemedica and Stemedica International
Stemedica Cell Technologies is a world leader in the manufacture of allogeneic adults stem cells. The company’s headquarters and primary manufacturing facility is located in San Diego, California. Based in Lausanne, Switzerland, Stemedica International is a wholly-owned subsidiary of Stemedica Cell Technologies, Inc. Stemedica Cell Technologies, Inc. is a specialty biopharmaceutical company that is committed to the development and manufacturing of best-in-class adult stem cells and stem cell factors for use by approved research institutions and hospitals for preclinical and human clinical trials. Stemedica is headquartered in San Diego, California.
http://www.stemedica.com

Stemedica Receives Approval From UCSD To Initiate Ischemic Stroke Study With Adult Allogeneic Stem Cells

2011-02-17T23:39:00.000-08:00

(Source: February 17 2011; Stemedica Cell Technologies, Inc.)
Stemedica Cell Technologies, Inc., a leader in adult allogeneic stem cell manufacturing, research and development announced today that it has received IRB approval from the University of California, San Diego (UCSD) to initiate a Stemedica clinical study entitled, “A Phase I/II, Multi-Center, Open-Label Study to Assess the Safety, Tolerability and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Mesenchymal Bone Marrow Cells to Subjects With Ischemic Stroke”. This study will enroll approximately 35 subjects with a clinical diagnosis of ischemic stroke. These patients have significant functional or neurologic impairment that confines them to a wheelchair or requires home nursing care or assistance with the general activities of daily living and have received the ischemic stroke diagnosis at least six months prior to enrollment in this study.

Michael Levy, MD, PhD, FACS Chief of Pediatric Neurosurgery at Children's Hospital San Diego (CHSD) and Professor of Neurological Surgery at the University of California, San Diego is the principal investigator of the study. Dr. Levy looks forward to enrolling patients, and reinforces the importance of clinical stem cell research. “This is an important step forward in translational medicine. This study may help pave the way for a new therapeutic category of treatment for ischemic stroke.”

Lev Verkh, PhD, Stemedica’s Chief Regulatory and Clinical Development Officer, commented, “We are pleased and delighted to be working with UCSD and Dr. Levy. We believe that progressing rapidly down the regulatory pathway may eventually provide treatment options for the 800,000 Americans who suffer a stroke each year.” According to the American Heart Association, stroke is the fourth leading cause of death, costing an estimated $73.7 billion in 2010 for stroke-related medical cost and disability.

The safety of stem cell treatment is of paramount concern to all stake holders in this emerging industry. Nikolai Tankovich, MD, PhD, President of Stemedica, highlights the Company’s relentless attention to this area. “As a cGMP government-licensed manufacturer of adult stem cells, we have also received an investigational new drug (IND) approval from the FDA for this clinical trial. Very few companies have this unique dual capacity. Our cells have gone through rigorous testing to make certain they are free from infectious agents and are not tumorigenic.”

Maynard Howe, PhD, Vice Chairman and CEO of Stemedica notes, “The medical and scientific community has much work to do in the prevention and treatment of stroke. Too many patients and family members have to cope with the aftermath of this disease. It is our hope that stem cell treatment may eventually ease the burden faced by patients and caregivers as well as curtail the extensive healthcare and rehabilitation costs.”

Information on enrolling in the study can be found at http://clinicaltrials.gov/ct2/results?term=stemedica.

About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies Inc. is a specialty biopharmaceutical company that is committed to the manufacturing and development of best-in-class allogeneic adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and clinical (human) trials. The company is a government licensed manufacturer of clinical grade stem cells and is approved by the FDA for its clinical trials for ischemic stroke. Stemedica is currently developing regulatory pathways for a number of medical indications using adult allogeneic stem cells. The Company is headquartered in San Diego, California.

Media Contact for Stemedica: Dave McGuigan at dmcguigan@stemedica.com

Stemedica Announces the Appointment of Dr. César Amescua Garcia as Medical and Regulatory Affairs Director – Latin America

2010-06-24T08:18:00.000-07:00

Stemedica Cell Technologies, Inc., a leader in allogeneic adult stem cell manufacturing, research and development announced today the appointment of César Amescua, MD as Medical and Regulatory Affairs Director for Latin America. Dr. Amescua will be responsible for liaison with regulatory agencies in Latin America regarding approvals of Stemedica’s stem cell products for use in clinical (human) trials which follow the criteria required by the FDA in the United States.

Dr. Amescua is a member of the senior medical leadership at Grupo Angeles, one of the largest health care providers in all of Latin America. He is also President of the Mexican Association for the Study and Treatment of Pain. “I am excited and proud to be working with Stemedica. The company is a leader in the stem cell manufacturing field, and is bringing innovative technology to countries around the world. Latin America holds great promise for Stemedica’s products and services as Latin America seeks to address the epidemic of degenerative diseases and conditions that are bankrupting health care systems around the world.”

Dr. Lev Verkh, Stemedica’s Chief Regulatory and Clinical Development Officer, commented, “We’re pleased and delighted to have Dr. Amescua joining our team at Stemedica. His medical leadership and his regulatory expertise will be critical in establishing clinical trials throughout Latin America using Stemedica stem cell products.”

“With the rapid advancement of the clinical application and development of adult stem cell therapy around the world, the addition of Dr. Amescua’s medical leadership and regulatory expertise is critical in establishing extensive clinical trials for our products,” said Dr. Nikolai Tankovich, Stemedica’s President and Chief Medical Officer.

About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies Inc. is a specialty biopharmaceutical company that is committed to the manufacturing and development of best-in-class allogeneic adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and clinical (human) trials. The company is a government licensed manufacturer of clinical grade stem cells and is approved by the FDA for its clinical trials for ischemic stroke. Stemedica is currently developing regulatory pathways for a number of medical indications using adult allogeneic stem cells. The Company is headquartered in San Diego, California.

Media Contact for Stemedica: Dave McGuigan at dmcguigan@stemedica.com

Dr. Maynard Howe, CEO of Stemedica, the Leading Allogeneic Adult Stem Cell Manufacturer, Joins USO Board of Governors

2010-06-11T07:22:00.000-07:00

SAN DIEGO, California. (June 11, 2010) Dr. Maynard A. Howe, CEO and Vice Chairman of Stemedica Cell Technologies Inc. (“Stemedica”), an allogeneic adult stem cell manufacturer, was welcomed as the newest member of the USO Board of Governors during their May Board Meeting held in San Antonio, Texas. Dr. Howe brings a richly diverse background to the USO as Chairman, CEO, COO, CTO, and Executive Vice President of Marketing and Sales of many organizations, while serving as a consultant to more than fifty Fortune 500 companies worldwide.

“We are excited to bring Maynard on board with the USO,” said Edward Reilly, Chairman of the USO Board of Governors. “His leadership, research and consulting experience will be a special asset to the USO as we expand our services to U.S. troops and their families.”

Dr. Maynard A. Howe, PhD, CEO and Vice Chairman of Stemedica Cell Technologies Inc.
Originally uploaded by Stemedica

Along with his brother, Roger, Dr. Howe launched five successful ventures in the medical device, software, testing and measurement, quality and consulting fields, including Stemedica. Stemedica is the world's leading developer, manufacturer and distributor of allogeneic adult stem cell technology. Stemedica recently received an IND approval from the FDA to initiate stem cell clinical research trials in the United States for ischemic stroke using allogeneic adult stem cells and outside of the United States for several other neurological trials.

“I’m honored and delighted to be a member of the USO Board of Governors,” said Dr. Howe. “I have always had a deep passion for supporting our dedicated soldiers. Joining the USO Board of Governors allows me to combine my passion, diverse contact base and medical knowledge in service to our troops.”

Dr. Howe is a sought after facilitator, lecturer and speaker. He holds a Bachelor of Science Degree in Business Management, Master of Science Degree in Educational and Counseling Psychology and a Doctorate in Clinical Psychology. He is the author and co-author of numerous articles and top selling business books. His book on quality, Quality on Trial, Bringing Customer Relationships into Focus, is in its second edition and has been published in several languages. Other books include a five-part implementation manual series, Business-to-Business Marketing Management System, published by McGraw-Hill.

About the USO The USO (United Service Organizations) lifts the spirits of America’s troops and their families. The USO provides a touch of home through centers at airports and military bases around the world, top quality entertainment and innovative programs and services tailored to meet troop needs. The USO also provides critical support to those who need us most, including forward-deployed troops and their families, wounded warriors and their families, and the families of the fallen. The USO is a private, non-profit organization, not a government agency; that relies on the generosity of our donors. For more information, please visit www.uso.org or contact Travis T. Burgin, USO, 703-740-4982.

About Stemedica Cell Technologies, Inc. Stemedica Cell Technologies Inc. (www.stemedica.com) is a specialty biopharmaceutical company that is committed to the development and manufacturing of best-in-class allogeneic adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and human stem cell clinical trials. The company is currently developing regulatory pathways for stroke and wound repair. Stemedica is headquartered in San Diego, California.

For more information regarding Stemedica Cell Technologies, Inc. contact Dave McGuigan at dmcguigan@stemedica.com.

Stemedica Announces the Appointment of Dr. Lev Verkh as Chief Regulatory and Clinical Development Officer

2010-06-01T22:33:00.000-07:00

Stemedica Cell Technologies, Inc., a leader in adult stem cell research and manufacturing, announced today the appointment of Lev Verkh, PhD as Chief Regulatory and Clinical Development Officer. Dr. Verkh will be responsible for managing all regulatory activities and clinical trials on behalf of the company. “Dr. Verkh brings over twenty years of international regulatory and clinical trial experience to Stemedica,” said Dr. Nikolai Tankovich, Stemedica's President & Chief Medical Officer. “We are confident that his contribution to our mission to bring innovative products to patients, following FDA guidelines, will be significant.”

Dr Lev Verkh, PhD appointed as Chief Regulatory and Clinical Development Officer.
Originally uploaded by Stemedica

Dr. Verkh's clinical and regulatory experience includes working for Pfizer, Baxter Bio Sciences, the Alliance Pharmaceutical Corporation and the Alpha Therapeutic Corporation. He has directed national and multi-national Phase I, II, III and IV clinical trials in such areas as cardiology, oncology, peripheral artery disease, hematology, blood disorders and imaging methods. He is author or co-author of over 40 peer-reviewed publications. Through his efforts and the efforts of his teams, he has received FDA approval for several products that are currently on the market. “I am honored to be joining Stemedica's management team,” said Dr. Verkh, “and am excited to work with the company’s leading-edge stem cell technology.”

In addition to directing Stemedica's clinical trials within the United States, Dr. Verkh will be assisting foreign regulatory agencies to establish guidelines for stem cell technologies in medicine. He will also assist in organizing and supervising clinical trials outside the United States utilizing Stemedica technology.

“With the rapid advancement of clinical application and development of adult stem cell technologies around the world, the addition of Dr. Verkh is essential to our long-term growth plan”, said Maynard Howe, PhD, Stemedica’s Chief Executive Officer. “Stemedica is working closely with government leaders, scientists and clinicians to establish and promote best scientific practices in the emerging field of stem cell research and therapy.”

About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies Inc. is a specialty biopharmaceutical company that is committed to the development and manufacturing of best-in-class adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and human clinical trials. The company is currently developing regulatory pathways for stroke, cardiomyopathy, diabetic retinopathy and wound repair. Stemedica is headquartered in San Diego, California.

Media Contact for Stemedica: Dave McGuigan at dmcguigan@stemedica.com

FDA Approves Stemedica IND Application for Ischemic Stroke Clinical Trial

2010-04-20T23:44:00.000-07:00

Stemedica Cell Technologies, Inc. (Stemedica), a world leader in stem cell research and manufacturing, announced that the U.S. Food and Drug Administration (FDA) approved its application for an Investigational New Drug (IND) for a clinical trial for ischemic stroke using Stemedica’s high potency proprietary allogeneic stem cells (adult human).

“The FDA acceptance of our IND application and the clinical protocol for usage of allogeneic mesenchymal bone marrow-derived stem cells in subjects with ischemic stroke is an important milestone for Stemedica in its development program,” said Nikolai Tankovich, MD, PhD, Stemedica’s President and Chief Medical Officer. “Currently, patients suffering from ischemic stroke have very limited treatment options. We hope that bringing this novel option to the medical community will help to alleviate the burden of a serious and disabling disease and will be valuable for both patients and their family members.”

The IND application approval allows Stemedica to initiate a planned clinical trial at medical centers within the United States. The clinical trial will be a Phase I/II dose escalation and safety clinical trial using allogeneic mesenchymal bone marrow cells administered intravenously to patients with ischemic stroke. The patient population will include individuals with significant functional or neurologic impairment related to the ischemic stroke that confines the subject to a wheelchair or requires the subject to have home nursing care or assistance with the general activities of daily living.

“This approval, along with the licensing of our cGMP manufacturing facility, are two important breakthroughs in our company’s evolution,” said Maynard Howe, PhD, Stemedica’s Vice Chairman & CEO. “It is a testament to the professionalism and focused persistence of our team.”

Stemedica is licensed by the State of California’s Department of Public Health, Food and Drug Branch to manufacture stem cells, drugs and biologic products for human clinical trials. The Company is compliant with both California law and the Code of Federal Regulations.

About Stemedica Cell Technologies

Stemedica Cell Technologies Inc. (www.stemedica.com) is a specialty biopharmaceutical company that is committed to the development and manufacturing of best-in-class adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and human clinical trials. The company is currently developing regulatory pathways for stroke and wound repair. Stemedica is headquartered in San Diego, California.

For more information regarding this Media Release or Stemedica Cell Technologies, contact Dave McGuigan at dmcguigan@stemedica.com.

Stemedica Files IND Application with FDA for Treatment of Stroke with Adult Allogeneic Mesenchymal Stem Cells

2010-03-19T00:46:00.000-07:00

(Source: March 19, 2010; Stemedica Cell Technologies, Inc.)

Stemedica Cell Technologies, Inc. (Stemedica), a world leader in stem cell research and manufacturing, announced that it has filed an Investigative New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for a clinical trial. The trial will assess the safety, tolerability and efficacy of Stemedica's high potency proprietary allogeneic mesenchymal bone marrow-derived stem cells (adult human) as a treatment for ischemic stroke.

The proposed clinical trial will be a Phase I/II dose escalation and safety clinical trial using allogeneic mesenchymal bone marrow cells administered intravenously to patients with ischemic stroke. The patient population will include individuals with significant functional or neurologic impairment related to the ischemic stroke that confines the subject to a wheelchair or requires the subject to have home nursing care or assistance with the general activities of daily living. The proposed trial will take place at medical centers within the United States.

“Stemedica achieved another milestone in its development program by moving from research to patient bedside to help people suffering from stroke,” said Nikolai Tankovich, MD, PhD, Stemedica’s President and Chief Medical Officer. “In addition to the official licensing of our manufacturing facility in San Diego, California, we have now established our own clinical trial pathway in compliance with FDA and FDB regulatory requirements. Stemedica’s goal is to receive regulatory approval of our mesenchymal stem cells for this clinical indication.”

“We are happy that Michael Levy, MD, PhD, Chief of Pediatric Neurosurgery at Rady Children’s Hospital of San Diego and Professor of Surgery at UCSD’s School of Medicine, will be the Principal Investigator leading our clinical trial,” said Maynard A. Howe, PhD, Vice Chairman and CEO, who added “Stemedica is committed to developing, manufacturing and distributing adult stem cells that have the potential to save, restore and improve lives. This mission is central to everything that Stemedica does and we are dedicated to executing this mission with great passion and scientific discipline.”

Stemedica was granted its license by the State of California’s Department of Public Health, Food and Drug Branch to manufacture stem cells for clinical trials in July, 2009. The Drug Manufacturing License grants Stemedica the right to manufacture clinical-grade (for human use) drug or biologic products and recognizes Stemedica as being compliant with California law and the applicable provisions of the Code of Federal Regulations.

About Stemedica Cell Technologies

Stemedica Cell Technologies Inc. (www.stemedica.com) is a specialty biopharmaceutical company that is committed to the development and manufacturing of best-in-class adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and human clinical trials. The company is currently developing regulatory pathways for stroke and wound repair. Stemedica is headquartered in San Diego, California.

For more information regarding this Media Release or Stemedica Cell Technologies, contact Dave McGuigan at dmcguigan@stemedica.com.

Prominent Health Care Executive Joins Stemedica Board Of Directors

2009-12-01T10:28:00.000-08:00

Anthony M. Marlon, MD was elected to the Stemedica Cell Technologies, Inc. (“Stemedica”) Board of Directors at the Company’s November 20th Board Meeting. Roger J. Howe, PhD, Executive Chairman for Stemedica made the announcement, “We are fortunate to have someone of Dr. Marlon’s experience, expertise and stature joining our Board. He brings first hand experience to our Board as a physician and as a prominent business leader within the health care industry for the past thirty seven years.”

Anthony M. Marlon, MD elected to the Stemedica Board of Directors
at the November 20th Board Meeting.
Originally uploaded by Stemedica

Dr. Marlon was Chairman of the Board and Chief Executive Officer of Sierra Health Services, Inc. (“Sierra”), a publicly traded healthcare company headquartered in Las Vegas, Nevada. Founded in 1984, Sierra was a diversified managed healthcare company that provided and/or administered benefit plans for employers, government programs and individuals predominately in Nevada. Sierra was comprised of a family of health-related subsidiaries including Health Plan of Nevada, Nevada’s largest health maintenance organization (HMO). In February of 2008, Sierra and its subsidiaries became part of United Healthcare where he was asked to serve as a consultant through February of this year.

Dr. Marlon was a member of the Board of Directors of America’s Health Insurance Plans (AHIP), and remains a Board Member of the Nevada Development Authority and the University of Nevada Las Vegas (UNLV) Foundation. In 1992, Dr. Marlon was appointed to the Federal Task Force on Long Term Health Care Policies. For thirteen years, Dr. Marlon’s leadership skills were called on as a member of the Government Affairs Committee of the Las Vegas Chamber of Commerce. “Dr. Marlon provides Stemedica with an expertise in health care development, regulatory approval processes and insurance reimbursement models that is unparalleled,” said Maynard A. Howe, PhD, Stemedica’s Vice Chairman & CEO. “Anthony will be invaluable to both our Board and our Senior Management as we help to pioneer regulatory and reimbursement models for countries around the world.”

Dr. Marlon was born in New York City. He attended the College of the Holy Cross in Worcester, Massachusetts where he received a Bachelor of Science degree in 1963. He earned his Doctor of Medicine degree at State University of New York in 1967. At Stanford University Hospital in Palo Alto, California, he served as a medical intern from 1967-1968; as an internal medicine resident from 1968-1970; and as a Cardiology Fellow from 1970-1972. Dr. Marlon moved to Las Vegas in July of 1972 and was affiliated with University Medical Center as Chief of the Division of Cardiology. Dr. Marlon has been a speaker for various medical institutions, universities, and health groups and has written numerous cardiology related articles for medical publications.

About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies Inc. develops and manufactures allogeneic adult stem cells sold worldwide for research and clinical purposes. Stemedica is headquartered in San Diego, California.

Media Contact for Stemedica: Dave McGuigan at dmcguigan@stemedica.com

Stemedica President Invited To Lecture At The University Of Oxford

2009-11-12T09:34:00.000-08:00

Nikolai Tankovich, MD, Ph.D., President and Chief Medical Officer of Stemedica Cell Technologies, Inc. was invited to lecture at a multi-disciplinary seminar at the Centre for Science and Society at Trinity College, a constituent college of the University of Oxford, England. The seminar, which focused on current research and medical applications for stem cells, was attended by more than 300 professors and staff representing all facets of the University.

Dr Nikolai Tankovich, President and Chief Medical Officer of Stemedica at the Centre for Science and Society at Trinity College, a constituent college of the University of Oxford, England

Dr. Tankovich gave a presentation to medical and business professionals on stem cell research and clinical applications entitled, “From Research Bench to Patient Treatment.” In his lecture, Dr. Tankovich presented detailed ideas and information on:

Novel pre-clinical and clinical research currently being conducted with stem cells.

Procedural standards on how stem cells must be properly sourced and manufactured in order to meet evolving legal and regulatory rules.

The regulatory requirements for cGMP facilities and licensed manufacturers.

Tests and studies that must be done prior to the implementation in clinical trials.

Types of governmental authorization required to begin clinical trials.

Business infrastructure requirements necessary to enter into clinical trials and beyond.

Dr. Tankovich also discussed Stemedica’s multinational collaboration efforts currently underway to bring stem cells from research laboratories to clinical trials on a worldwide basis.

"I was very proud to be invited to lecture at an institution as prominent as Oxford University's Trinity College," said Dr. Tankovich. "Significant contributions to stem cell research have been made by Oxford University scientists and clinicians and it was my honor to present the research, pre-clinical and clinical applications currently being advanced by Stemedica through our various development & manufacturing activities."

Following Dr. Tankovich’s lecture, a number of positive discussions took place between Dr. Tankovich and those present regarding potential research collaborations between Oxford University and Stemedica. Numerous scientists, doctors, and teaching professors, having expressed a strong interest in knowing more about Stemedica’s research, stem cell & stem cell factors product line as well as Stemedica’s Business Model, were invited by Dr. Tankovich to visit Stemedica and its cGMP compliant, FDB (Food & Drug Branch) licensed manufacturing facility in San Diego, California.

Dr. Frank C. Schuller, Director of the Centre for Science and Society at Trinity College said, "Many members of various departments including, Physiology, Biology and the Medical School at John Radcliff Hospital were present and several were quoted as saying that they thought this was one of the premiere seminars on stem cells ever offered at Oxford. Based upon Dr. Tankovich’s presentation and the response that it received, Stemedica can look forward to several collaborative initiatives evolving with Oxford over the coming months. Finally, a number of the participants at the Seminar commented that Dr. Tankovich’s presentation will help them frame their own research in a more efficient and effective way as they proceed from bench top research to controlled clinical application. This is of great benefit to efforts taking place here at Oxford."

About The Centre for Science and Society
The Centre for Science and Society addresses contemporary issues and problems resulting from emerging technologies that affect society and public policies.

About Stemedica Cell Technologies, Inc.
Stemedica is a specialty biopharmaceutical company that is committed to the development and manufacture of best-in-class adult stem cells for use by approved research institutions and hospitals for pre-clinical and clinical studies. Within the United States, the Company is currently developing regulatory pathways for stroke, traumatic brain injury and wound repair. Outside the United States, Stemedica provides its adult stem cells to hospitals and research centers that are conducting studies under protocols approved by the appropriate regulatory agencies. These studies are focused on the treatment of neurodegenerative disease, sight restoration and wound repair. Stemedica is based in San Diego, California

Media Contact for Stemedica: Dave McGuigan at dmcguigan@stemedica.com

Stemedica Completes Meeting with the FDA

2009-10-15T01:48:00.000-07:00

Stemedica Cell Technologies, Inc. (Stemedica), a world leader in stem cell research and manufacturing, announced that it completed its pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding a proposed IND (Investigative New Drug) to evaluate the safety and efficacy of Stemedica's high potency proprietary allogeneic mesenchymal bone marrow-derived stem cells (adult human) as a treatment for ischemic stroke. Based on a meeting October 13, 2009 with the FDA, Stemedica is planning to file an IND application in the first quarter of 2010.

The proposed clinical trial will be a Phase I/II dose escalation and safety clinical trial using allogeneic mesenchymal bone marrow cells administered intravenously to patients with ischemic stroke. The patient population will include individuals with a clinical diagnosis of chronic neurological or age-related neurodegenerative disease with significant functional or neurologic impairment that confines the subject to a wheelchair or requires the subject to have home nursing care or assistance with the general activities of daily living. The proposed trial will take place at medical centers within the United States.

“This is an important milestone for Stemedica,” said Nikolai Tankovich, MD, PhD, Stemedica’s President and Chief Medical Officer. “In addition to the official licensing of our manufacturing facility in San Diego, California, we can now establish our own clinical trial pathways for our various products. Stemedica’s goal is to receive regulatory approvals for the clinical application of all of its products.”

“With constructive feedback from the FDA we can work on fine-tuning the proposed treatment protocol and advance our proposed clinical trial to targeted medical facilities for full consideration,” said Michael Levy, MD, PhD. Dr. Levy is the Chief of Pediatric Neurosurgery, Rady Children’s Hospital of San Diego, Professor of Surgery, UCSD School of Medicine and the Principal Investigator for the proposed clinical trial.

Stemedica was granted its license by the State of California’s Department of Public Health, Food and Drug Branch to manufacture stem cells for clinical trials in July, 2009. The Drug Manufacturing License grants Stemedica the right to manufacture clinical-grade (for human use) drug or biologic products and recognizes Stemedica as being compliant with California law and the applicable provisions of the Code of Federal Regulations.

About Stemedica Cell Technologies
Stemedica Cell Technologies Inc. (www.stemedica.com) is a specialty biopharmaceutical company that is committed to the development and manufacturing of best-in-class adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and human clinical trials. The company is currently developing regulatory pathways for stroke and wound repair. Stemedica is headquartered in San Diego, California.

For more information regarding this Media Release or Stemedica Cell Technologies, contact Dave McGuigan at dmcguigan@stemedica.com.

United States Patent and Trademark Office Publishes Stemedica's Patent Application for the Treatment of Diabetic Retinopathy

2009-09-08T22:23:00.000-07:00

Stemedica Cell Technologies, Inc. USA, a world leader in stem cell research and manufacturing, has filed a patent application with the United States Patent and Trademark Office ("USPTO") for a proprietary methodology in the treatment for Diabetic Retinopathy. The patent application was published by the USPTO on August 27th of this year. The application is supported by extensive data and results from patients treated within a Clinical Study conducted outside of the United States beginning in January of 2006.

"Our patent application describes a dynamic method for treating diabetic retinopathy and other degenerative conditions of the eye," said Nikolai Tankovich, MD, PhD, Stemedica's President and Chief Medical Officer. "The breakthrough results from this study provide new hope for the thousands of patients suffering from the debilitating disease of Diabetic Retinopathy."

Stemedica's invention relates to the use of multiple stem cells and a transplantation methodology in the treatment of Diabetic Retinopathy. Participating patients had varying degrees of Diabetic Retinopathy and Diabetic Optic Neuropathy. Patients received neural progenitor cells by retrobulbar injection and mesenchymal stem cells administered intravenously. Patients were observed at baseline and then after treatment at days 2, 8, 14, 30, 60, 90, and 120. Annual physical and ophthalmic examinations were conducted each year thereafter for a three year period.

Noticeable patient findings included: overall visual function improvements by all eight patients within sixty (60) days of treatment; reduction in absolute scotomas; increases in the thickness of the optic nerve fiber; resorption of hemorrhages; no new micro bleeding edema of the nerve fiber layer; and, a decrease in macular edema. Improvement in the function of different layers of the retina and optic nerve were experienced as well as a reduction in the number of scotomas in the field of vision. None of the patients developed tumors, had impaired vision or experienced adverse health effects connected with the cell injections, and seven of the eight participating patients have maintained the overall vision improvements they gained from treatment three years later.

Diabetic retinopathy is damage to the eye's retina that occurs with long-term diabetes. It is a leading cause of adult blindness in the United States.

This patent application, Publication Number US2009/0214485 A1, is available for review via the USPTO at http://www.uspto.gov.

About Stemedica Cell Technologies, Inc. Stemedica Cell Technologies Inc. (www.stemedica.com) is a specialty biopharmaceutical company that is committed to the development and manufacturing of best-in-class adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and human clinical trials. The company is currently developing regulatory pathways for stroke and wound repair. Stemedica is headquartered in San Diego, California.

For more information regarding this Media Release or Stemedica Cell Technologies, contact Dave McGuigan at dmcguigan@stemedica.com.

The Jordanian Stem Cell Company Acquires Stem Cell Technology From Stemedica International SA - First Clinical Trail Anticipated To Begin Early 2010

2009-09-08T22:20:00.000-07:00

Stemedica Cell Technologies, Inc., (“Stemedica”), a world leader in stem cell research and manufacturing, announced the signing of an agreement today for its breakthrough stem cell and related technology. The Jordanian Stem Cell Company has signed a five year multi-million dollar agreement to purchase the technology from Stemedica's wholly-owned subsidiary, Stemedica International, S.A. The signing ceremony took place at the European Burns Association Congress in Lausanne, Switzerland.

Mr. Sam Alkhass, CEO of The Jordanian Stem Cell Company and Dr. Frank Schuller, Chairman, Stemedica International SA sign multi-year agreement between the two companies.
Originally uploaded by Stemedica

"This is an important day for Stemedica International," said Frank Schuller, PhD, Stemedica International's Chairman. "This is a real testament to the quality and integrity of our products and the experience, dedication and professionalism of our team." The signing ceremony was attended by Mr. Sam Alkhass, Chief Executive Officer of the Jordanian Stem Cell Company as well as several representatives from Stemedica, including Dr. Schuller; Mark Tager, MD, Executive for Stemedica's Dermatological Operations; Alex Kharazi, MD, PhD, Stemedica's Vice President for Research and Manufacturing; and, Riccardo Nisato, MBA, PhD, Director of Manufacturing and Business Development, Stemedica International S.A.

"We are delighted to be working with Stemedica International," said Sam Alkhass. "Jordan has an excellent reputation as a provider of innovative and quality-driven medical treatment. It was fundamental to our company's future, and Jordan's reputation, that we find the best possible partner within the stem cell industry. We believe we have accomplished this objective by securing a long-term exclusive relationship with Stemedica International." Headquartered in Amman, The Jordanian Stem Cell Company is Chaired by His Royal Highness, Prince Asem Bin Nayef.

"We would like to thank the Jordanian Stem Cell Company and its Chairman, His Royal Highness, Prince Asem Bin Nayef for their vision and long-term commitment in bringing adult stem technology to Jordan," said Roger J. Howe, PhD, Chief Executive Officer for Stemedica International and Executive Chairman for Stemedica. "Our working relationship will not only provide significant medical advancements in treating the Citizens of Jordan, but will allow the country to continue to build on its growing reputation as a, "Center of Medical Excellence" for the entire region. We have a quality partner in The Jordanian Stem Cell Company and in the Country of Jordan and we look forward to growing these relationships."

"Stemedica International will be providing our state-of-the-art stem cell technology to the Jordanian Stem Cell Company and will actively support their development and implementation of a Clinical Trial for burns," said Nikolai Tankovich, MD, PhD, Stemedica's President and Chief Medical Officer and Vice Chairman of Stemedica International. "We will work closely with the leadership of the Jordanian Stem Cell Company to secure all necessary governmental approvals for the Clinical Trial. The Trial is anticipated to begin sometime in the first quarter of 2010."

Stemedica International S.A. is a Lausanne, Switzerland-based, wholly owned subsidiary of Stemedica Cell Technologies, Inc. headquartered in San Diego, California. Stemedica is a developer and manufacturer of clinical grade stem cell products and is licensed by the State of California Food and Drug Branch.

About Stemedica Cell Technologies

Stemedica Cell Technologies, Inc. (www.stemedica.com) is a specialty biopharmaceutical company that is committed to the development and manufacturing of best-in-class adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and human clinical trials. The company is currently developing regulatory pathways for stroke and wound repair. Stemedica is headquartered in San Diego, California.

For more information regarding this Media Release or Stemedica Cell Technologies, contact Dave McGuigan at dmcguigan@stemedica.com.

Stemedica Achieves Major Milestone - Company Receives License to Manufacture Clinical Grade Stem Cells

2009-09-01T06:12:00.000-07:00

(Source: September 1, 2009; Stemedica Cell Technologies, Inc.)

Stemedica Cell Technologies, Inc., (“Stemedica”), a leader in adult stem cell research and manufacturing, announced today that it has been granted a license by the State of California’s Food & Drug Branch to manufacture stem cells for human clinical trials. This Drug Manufacturing License recognizes Stemedica as being compliant with California law and the applicable provisions of the Code of Federal Regulations.

From left - Dr. Alex Kharazi, MD, PhD, Vice President Research and Manufacturing for Stemedica is joined by Eugene Helsel (Left), Sr. Director of Quality and Carl Bullen, (Right) Director of Manufacturing in accepting the California cGMP Manufacturing License.
Originally uploaded by Stemedica

“This is an important development for Stemedica,” said Nikolai Tankovich, MD, PhD, President and Chief Medical Officer of Stemedica. “With this license we become an even stronger worldwide leader within the stem cell industry. Our stem cells and stem cell-derived factors can now be purchased by pharmaceutical and biotech companies, research institutions and medical facilities conducting approved human clinical trials. As more and more organizations get involved with stem cell research and clinical trials, including drug discovery programs, Stemedica’s ability to service their needs becomes a critical asset to the organization and to the industry.”

“This stamp of approval positions Stemedica as one of only a few companies in the world capable of manufacturing and delivering its own unique multiple cell products and factors. The Company also has the ability to custom manufacture for select companies. These dynamic capabilities give us a significant point of advantage in the marketplace.” said Roger Howe, PhD, Executive Chairman for Stemedica.

Stemedica has dedicated significant financial and human resources over the past four years in preparation for securing this license. The government’s rigorous inspection and approval process has included: a comprehensive, in-depth audit of Stemedica’s manufacturing process and procedures; examination of Stemedica’s Quality Systems; interviews with facility management; and an onsite inspection of the facility.

“We’re very proud of the hard work, dedication and professionalism of the team that has made this possible.” stated Maynard Howe, PhD, Stemedica’s Vice Chairman and Chief Executive Officer. “Their experience and expertise has been instrumental in assuring that our facility meets regulatory compliance requirements. With the approval and licensing process behind us we can now focus our efforts on manufacturing the highest quality stem cell products.”

About Stemedica Cell Technologies

Stemedica Cell Technologies, Inc. (www.stemedica.com) is a specialty biopharmaceutical company that is committed to the development and manufacturing of best-in-class adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and human clinical trials. The company has currently filed a pre-IND request with the FDA in preparation of IND submissions for stroke and wound repair. Stemedica is headquartered in San Diego, California.

For more information regarding this Media Release or Stemedica Cell Technologies, contact Dave McGuigan at dmcguigan@stemedica.com.

As released via PRWeb

Stemedica Selected by World Stem Cell Summit to Present Scientific Discoveries

2009-08-27T11:52:00.000-07:00

Stemedica Cell Technologies, Inc., (“Stemedica”), a world leader in stem cell research and manufacturing (a licensed manufacturer of clinical grade biological products as licensed by the State of California Food and Drug Branch) continues to advance the stem cell industry with the presentation of two of its latest scientific discoveries at the 2009 World Stem Cell Summit. “We are honored to have the work of our scientific research team selected for presentation at this year’s Summit. This work is expected to increase the efficacy and significantly reduce the time and cost in bringing important research from the bench top to clinical application,” said Nikolai Tankovich, MD, PhD, Stemedica’s President and Chief Medical Officer.

From left - Drs Ludmila Kharazi, MD, PhD and Chih-Min Lin, PhD
Originally uploaded by Stemedica

The first discovery accepted by the Summit’s Peer Review Committee was submitted by Chih-Min Lin, PhD, a Stemedica Senior Research Scientist. His submittal is entitled, “Chicken Embryonic Brain: A Model for Testing Neural Stem Cell Potency”. This Neural Stem Cell Evaluation Model determines the potency of neural stem cells and quickly assesses their ability to migrate and engraft inside the developing brain. Stemedica’s technology allows neural precursors to be distinguished at various stages of their maturation, providing timely and cost effective verification of neural stem cell potency in vivo.

“The currently used process for assessing the in vivo potency of neural stem cells in newborn mice is extremely time consuming and expensive. This traditional process also involves the use and sacrifice of animals in facilities separate from manufacturing. Stemedica’s discovery and patent pending technology eliminates the need for animals and replaces this arduous process with a significantly more effective and efficacious model. This model can be deployed within laboratory environment and the evaluation results can be attained in less than two weeks instead of the two to four months using traditional animal testing models,” said Alex Kharazi, MD, PhD, Stemedica’s Vice President of Research and Manufacturing.

Neural stem cell migration from the brain ventricle through brain tissue
Originally uploaded by Stemedica

The second finding accepted for presentation at the 2009 World Stem Cell Summit was submitted by Ludmila Kharazi, MD, PhD, Stemedica’s Senior Research Scientist. Her submittal is entitled, “Up-Regulation of Wound Healing Associated Proteins in Long-Term Culture of Human Keratinocyte Precursor Cells.” Dr. Kharazi’s work demonstrates that long term cultivation of human keratinocytes in serum free, low-Ca++ media (SFM) leads to the increased expression of genes for wound healing-associated proteins such as fibronectin, metalloproteinase (MMP9, MMP10), and tissue-type plasminogen activator (TPA). The purpose of Dr. Kharazi’s work was to determine how the propagation of human skin keratinocyte precursor cells (KPC) in SFM to clinically significant numbers will affect their ability to produce fibronectin and other wound healing associated proteins.

“Current technology for the treatment of burns, chronic wounds and diabetic ulcers is extremely expensive, time consuming and lacking in efficacy. Dr. Ludmila Kharazi’s finding suggests that using long term cultivated keratinocyte precursor cells may result in reducing the time of healing while lowering the overall treatment cost. As Stemedica continues to make great advancements in products that can treat burns, chronic wounds and diabetic ulcers, Dr. Ludmila Kharazi’s work is pivotal in providing the Company with advancements that will make our products, and ultimately patient treatment results, the best the industry has to offer,” said Dr. Tankovich. This finding compliments Stemedica’s existing proprietary burn and wound care product currently in clinical trials in Switzerland.

The 2009 World Stem Cell Summit is being held in Baltimore, Maryland from September 21st – 23rd. Presented by the Genetics Policy Institute, the 2009 Summit is hosted by Johns Hopkins University and other leadership organizations from within the stem cell industry, bringing together more than 1,200 researchers, clinicians, business leaders, key policy makers, regulators, advocates, and experts in law & ethics from around the world.

Licensing of the Stemedica’s Neural Stem Cell Evaluation Model Intellectual Property is available to a select number of companies. Additionally, Stemedica is prepared to accept a limited number of projects where the Company’s scientific team conducts the neural stem cell potency evaluation.

About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies Inc. (www.stemedica.com) is a specialty biopharmaceutical company that is committed to the development and manufacturing of best-in-class adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and human clinical trials. The company is currently developing regulatory pathways for stroke and wound repair. Stemedica is headquartered in San Diego, California.

For more information regarding this Media Release or Stemedica Cell Technologies, contact Dave McGuigan at dmcguigan@stemedica.com.

Stemedica Requests Pre-IND Meeting With FDA

2009-08-21T05:59:00.000-07:00

Stemedica Cell Technologies, Inc. USA, a leader in adult stem cell research and manufacturing, has requested a pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration ("FDA") to discuss a proposed IND to use Stemedica's proprietary line of allogeneic mesenchymal bone marrow cells (adult human) as a treatment for ischemic stroke.

Stroke is a leading cause of adult impairment, with 20% of stroke survivors requiring institutional care after 3 months and up to 30% severely and permanently disabled. The only approved treatments of acute ischemic stroke involves restoring blood flow to the affected region by using thrombolytics or mechanical devices that physically remove clots. However, the use of thrombolytics (tPA) is limited due to the therapeutic window of < 3-6 hours post onset of stroke symptoms such that only a small fraction of stroke patients receive this therapy.

"Following a stroke, there is little therapy to offer patients to promote recovery other than physical, occupational, and speech therapy," said Nikolai Tankovich, MD, PhD, President & Chief Medical Officer. "Treatment with allogeneic mesenchymal bone marrow cells may offer new hope to patients with chronic neurological or age-related, neurodegenerative diseases."

Allogeneic mesenchymal bone marrow cells are obtained from donors by extracting bone marrow and are expanded at Stemedica's cGMP compliant facility, which is licensed by the California Department of Public Health, Food and Drug Branch. "Stemedica's facility will manufacture clinical grade stem cells as it prepares for FDA approval of an IND to begin clinical trials," said Maynard Howe, PhD, Vice Chairman and CEO of Stemedica.

About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies Inc. (www.stemedica.com) is a specialty biopharmaceutical company that is committed to the development and manufacturing of best-in-class adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and human clinical trials. The company is currently developing regulatory pathways for stroke and wound repair. Stemedica is headquartered in San Diego, California.

For more information regarding Stemedica Cell Technologies, Inc. contact Dave McGuigan at dmcguigan (at) stemedica.com.

Media contact:
Dave McGuigan
Stemedica Cell Technologies, Inc.
+1 858 658 0910

Stemedica Discovers Significant Breakthrough in the Use of Stem Cells and Stem Cell Factors for the Treatment of Retinal Degeneration

2009-07-01T05:56:00.000-07:00

Stemedica Cell Technologies, Inc., (“Stemedica”), a leader in the manufacturing and development of clinical grade allogeneic adult stem cell technology, has discovered a significant breakthrough in the use of human stem cells and stem cell factors for the potential treatment of degenerations of the retina and retinal pigmented epithelium. Retinal degenerations include diseases such as Retinitis Pigmentosa, which are hereditary conditions in which abnormalities of the retinal pigmented epithelium (RPE) within the eye lead to progressive vision loss. According to one of the study’s Principle Investigators, Dr. Paul Tornambe, “The results from this pre-clinical experiment are exciting. It allows researchers and clinicians to push the envelope in the quest to use stem cells to modulate diseases like Retinitis Pigmentosa.” There is currently no medical treatment that can completely cure Retinitis Pigmentosa – an eye disease that affects approximately 1,500,000 people on a worldwide basis each year.

A) Eye Release Factor Effect on non-treated eye. B) Eye injected with RPE stem cells. C) No injection in either eye..
Originally uploaded by Stemedica

An international consortium of prominent researchers and clinicians were assembled by Stemedica to fully explore the application of its proprietary lines of stem cells and stem cell factors for treatment of Retinal Degeneration in a pre-clinical environment. Their discoveries provide great promise for treating this disease at a clinical level. “We knew the team assembled had the experience and expertise to fully explore how stem cells and stem cell factors might be applied in the possible treatment of Retinal Degeneration that may apply to Retinitis Pigmentosa in the future”, said Nikolai Tankovich, MD, PhD, Stemedica’s President and Chief Medical Officer. “While there have been similar results achieved with our stem cells and factors in the experimental treatment of neurological diseases, we did not expect that these efforts would provide the kind of breakthrough results that have been achieved in our ophthalmological study.

The study team was comprised of Edwin Boldrey, MD, a Retina and Vitreous Specialist from Northern California and Charter Member of American Society of Retina Specialists and by Paul Tornambe, MD, of Retinal Consultants in San Diego, California. Dr. Tornambe is a past President of the American Society of Retina Specialists. Other members of the study team included Khristo Takhchidi, MD, PhD; Director General, Natalia Gavrilova, MD, PhD, Professor; and, Olga Komova, MD from the famous Fyodorov Eye Microsurgery Institute in Moscow, Russia. Supporting the principle investigators were Alexander Revischin, PhD, and Irina Saburina, MD, PhD from the Russian Academy of Sciences and by Alexei Lukashev, PhD, of Stemedica’s Research Lab in San Diego, California.

Dr. Tornambe identified several observations that resulted from the group’s efforts, ”There were two very encouraging findings: RPE stem cells injected into the suprachoroidal space prevented the animal’s RPE cell’s degeneration as well as preventing degeneration of the overlying photoreceptors proven by very objective ERG testing and histopathology. Secondarily, and even more interesting, is that the fellow contra lateral eye also showed a beneficial effect. This crossover effect suggest this treatment stimulated upregulation of other factors, yet unknown, which decreased the rate of degeneration in the fellow eye. Degeneration of RPE cells occur in many other human retinal diseases such as age related macular degeneration. It is very important to temper initial enthusiasm with the test of time, however, this study strongly suggests, at least in this animal model, that certain kinds of stem cells and factors can modify a disease process.”

The eighteen month pre-clinical study was implemented at the Fyodorov Eye Institute using Stemedica’s proprietary multiple cell technology. Three different types of human stem cells (hSC) were used in the study - retinal pigment epithelium (RPE), neural (NSC) and cilliary body (CB) – all obtained from human donor tissue. Various cells were injected into rats with hereditary pigmented degradation of retina. One eye of each participating rat served the treatment eye and the other eye served as the control eye. Healthy non-dystrophic and non-treated (normally dystrophic) animals were also used as independent control groups. Electroretinography (ERG) and immunohistochemical (ICH) analysis was performed on both eyes. “What is very impressive is the immune privileged feature of all three kinds of human stem cells (RPE, CB, NSC) in xenotransplantation. This immune privilege amplifies the significant promise of allogeneic donor stem cells in the treatment of retinal degenerative diseases”, stated Dr. Edwin Boldrey.

The research team compared the efficacy of each of the three cell types. A summary of the results yielded the following observations and discoveries:

The study showed a statistically significant gain (77%) in the treated eye (with RPE cells) over the control eye of the same animal. However, both the treated eye and the control eye were approximately 10 times more active (response to ERG) compared to non-treated (normally dystrophic) control animal.

The RPE and NSC cells were effective in preserving the thickness of the outer nuclei layer of the retina.

A contra lateral effect was observed between the test and control eyes. As a result, both eyes exhibited significant improvement. It is believed that the positive outcome in the control eye was achieved through the systemic release of cytokines; growth and other important factors; peptides; and, molecules from stem cells transplanted into the treated eye. This phenomenon is referred to by Stemedica as “The Factor Release Effect” and branded by the company as StemedicaFRE™. These factors, circulating in the blood flow, effect and mobilize endogenous stem cells. Stemedica believes improvement in the contra lateral eye is a ‘Factor Release Effect’ rather than a Sympathetic Ophthalmic effect which is very rare. Stemedica discovered the presence of these endogenous RPE stem cells in adult retinas several years ago. This original research demonstrated that these RPE stem cells acquired embryonic markers (Nanog and Oct-4) in adult humans.

“Stemedica has filed a number of patent applications to secure the rights for these discoveries - the use of our stem cells and their factors in the treatment of a variety of neurodegenerative diseases and conditions. Based upon the results from the work of this luminary group, we have focused our legal protection and Intellectual Property efforts to include the treatment of Retinitis Pigmentosa and ways to prevent its development and progression”, said Timothy Brown, MS, JD, Director of Stemedica’s Intellectual Property Department.

The results from the study will be presented at the Retina Congress in New York, September 30, 2009. The Retina Congress is a worldwide gathering of the most established and accomplished retina doctors in the world. The Congress is sponsored by the American Society of Retina Specialists, the Retina Society and the Macular Society and represents over 2,000 retina and eye specialists from 54 countries.

“The discovery of the effect of stem cell factors supports our other clinical evidence substantiating how stem cells and stem cell factors can be isolated and used for the treatment of complex medical conditions. Clinical studies in countries outside of the United States have already demonstrated the efficacy of Stemedica’s stem cells and their factors in the experimental study treatment of diabetic retinopathy and other conditions. Based upon this breakthrough discovery and validation of our previous evidence, Stemedica has begun negotiations with a select number of potential strategic partners. Our goal is to rapidly advance our findings into a comprehensive clinical application”, said Maynard A. Howe, PhD, CEO and Vice Chairman of Stemedica.

Edwin Boldrey, MD
Dr. Edwin Boldrey is currently a Clinical Associate Professor of Ophthalmology at Stanford University and is President of Northern California Retina Vitreous Associates. He is a graduate of Northwestern University Medical School in Chicago and completed a Vitreo-Retinal Fellowship at Barnes Hospital, Washington University, St. Louis. He is the recipient of honors and awards from the American Academy of Ophthalmology, the Heed Ophthalmic Foundation and the Department of Ophthalmology, University of California, San Francisco. He was the Executive Secretary-Treasurer of the Western Retina Study Club, and is a Fellow of the American College of Surgeons. He is a member of Ophthalmological Organizations including: American Academy of Ophthalmology, The American Society of Retina Specialists, The Retina Society and The California Association of Ophthalmology. He is the author of more than 30 peer reviewed publications and has presented 114 papers and courses.

Paul Tornambe, MD
Dr. Paul Tornambe is former President of the American Society of Retina Specialists and presently sits on the Board. He has been a member of over a dozen Ophthalmology and Professional Medical Societies including Fellow – American College of Surgeons, American Academy of Ophthalmology, and California Medical Association. He has participated as Chief of Surgery and Chief of Staff at Pomerado Hospital and participated on the Board of Scripps Health Physicians and actively operated at both Scripps La Jolla and Pomerado Hospitals. He completed his Retina Fellowship training at Barnes Hospital, Washington University, St Louis. He is the recipient of numerous awards from the American Academy of Ophthalmology; American Society of Retina Specialists and was named among “The Best Doctors in America, 2000-2003” along with “Best Doctors in San Diego, 2002-2005”. He was recognized by the American Academy of Ophthalmology on their Centennial as a physician who made a major contribution in the field of Retina over the last 100 years for his work with gas bubbles to repair retinal detachments. Tornambe is the author of over 40 major peer reviewed scientific publications.

Khristo P. Takhchidi, MD, PhD
Khristo P. Takhchidi, is the Director General of the S.N. Fyodorov Federal Institution “Eye Microsurgery Complex”, Professor and the Chairman of Ocular Diseases of the Moscow State Medical University. He received his MD degree in 1976 at Sverdlovsk State Medical University. In 1987 he was appointed the Director of the Ural Branch of the Intersectional Research and Technology Complex “Eye Microsurgery”. The IRTC Ural Branch was built and put into operation under his direct leadership. As the Chief of the Clinic, over 260,000 operations were performed and approximately 800,000 patients received diagnostic - consulting service. In 2001 Takhchidi was appointed the Director General of the S.N. Fyodorov Federal Institution “Eye Microsurgery Complex”. He is an author of over 250 scientific publications, has been the Chair of Ophthalmology Society of Russia since 2005 and was appointed the Chief Expert for ophthalmology of the Russian Federal Inspection for Public Health and Social Development in 2006. Takhchidi is the Fellow of numerous International Ophthalmic societies and a recipient of many prestigious and honorable national and international awards.

The Fyodorov Center for Eye Microsurgery
The S.N. Fyodorov Federal State Institution “Eye Microsurgery Center” is the leading clinical and research ophthalmological center in Russia with over 4,000 researchers and medical doctors. The Center, along with its 11 affiliated branches including Clinics in Russia’s largest cities, treat 700,000 patients annually, performing 50% of the highly technological ophthalmic surgeries and over 30% of all ophthalmic aid in Russia.

About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies Inc. (www.stemedica.com) is a specialty biopharmaceutical company that is committed to the development and manufacture of clinical grade allogeneic stem cells for use by approved research institutions and hospitals for pre-clinical and clinical studies. Within the United States, the Company is currently developing regulatory pathways for stroke, traumatic brain injury and wound repair. Outside the United States, Stemedica provides its adult stem cells to hospitals and research centers that are conducting studies under protocols approved by the appropriate regulatory agencies. These studies are focused on the treatment of neurodegenerative disease, sight restoration and wound repair. Stemedica is based in San Diego, California.

Renowned Stem Cell Researcher Files Study Results With Stemedica

2009-03-18T01:21:00.000-07:00

Stemedica Cell Technologies, Inc., ("Stemedica"), a leader in adult stem cell research and manufacturing, received the results today from a Stemedica-sponsored clinical study conducted by renowned stem cell researcher and clinician Professor Philippe Hernigou, MD, Ph.D. The approved clinical study featured Dr. Hernigou's treatment of non-union bone injuries using autologous stem cells, allogeneic stem cells and comparative traditional treatment therapies.

Left to Right: Dr. David Howe, Dr. Nikolai Tankovich, Dr Philippe Hernigou, Dr Michael Bayer
Originally uploaded by Stemedica

"The results that Dr. Hernigou presented to our Company's leadership are both exciting and profound. First of all, the results reaffirm our assumptions about the short and long term safety of adult stem cells in general and our mesenchymal bone marrow stem cell line in particular. Secondarily, study results clearly showcase the regenerative nature of adult stem cell therapy in comparison to other traditional treatments", said Dr. Nikolai Tankovich, Stemedica's President and Chief Medical Officer. "We are delighted with the outcomes for this study as well as the insights that someone of Dr. Hernigou's stature can bring to a study of this kind", Dr. Tankovich commented.

The year-long study conducted by Dr. Hernigou and his staff included sixty patients who experienced tibia fractures that wouldn't heal. The study was a part of an on-going, ten year study involving nearly four hundred patients by Dr. Herningou using stem cell therapy and traditional treatment of non-union bones and joints. The Stemedica study results gave clear evidence that the use of adult stem cells provided greater healing capability in a shorter period of time with less infection. "I started treating non-union injuries using autologous stem cells back in 1990. This was followed by the clinical application of allogeneic stem cells seven years later in 1997. Through each and every year of the last seventeen years, and through each and every study I'm involved in, I become more convinced of the important role that adult stem cells play in the healing and bone regeneration process", said Dr. Hernigou.

Dr. Hernigou, MD, is Chief of the Orthopedic Surgery department at the Henri Mondor Hospital and is a professor of orthopedic surgery at the University of Paris XII, France, a position he has held since 1989. He is regarded as a pioneer, and one of the world's foremost authorities, in the use of stem cells in orthopedic surgery. Since 1990, Dr. Hernigou has developed new treatments for osteonecrosis first with cementoplasty, then with stem cells and later with growth factors. He has applied these techniques to more than 1,600 patients - from treating osteonecrosis in relation to sickle cell disease to the use of bone marrow grafts in the treatment of delayed unions and non unions. Dr. Hernigou has published more than 200 international scientific publications and has participated in more than 100 scientific conferences all over the world. He is a member of the International Orthopedic society and member of the International Hip Society.

Stemedica Announces the Appointment of Carl Bullen as Director of Manufacturing

2009-03-05T23:37:00.000-08:00

Stemedica announced today the appointment of Carl Bullen as Director of Manufacturing. Mr. Bullen will be responsible for manufacturing systems and procedures at Stemedica's San Diego-based manufacturing facility that is built to cGMP standards and is currently pending FDB license. Mr. Bullen has extensive experience in all aspects of cell culture manufacturing as well as the commercialization of new biomedical technologies for United States and European markets.

Carl Bullen, Director of Manufacturing
Originally uploaded by Stemedica

"We are very impressed with Mr. Bullen's track record of establishing and managing manufacturing systems in progressive technologies. His managerial experience combined with his knowledge of international regulatory requirements is a significant advantage as we prepare to supply our adult allogeneic stem cell lines to preclinical and clinical research centers around the world," said Dr. Nikolai Tankovich, Stemedica's President and Chief Medical Officer.

Mr. Bullen has been in the pharmaceutical manufacturing business for the past 16 years having started his career as a Biochemical Technician and progressing to Director of Manufacturing for such companies as IDEC Pharmaceuticals, Biogen Idec, Genentech and Pacira Pharmaceuticals. During the course of his extensive career, Mr. Bullen has employed his innovative thinking and manufacturing experience to develop practical solutions that have supported numerous start-up manufacturing scenarios for some of the world's foremost biotech companies.

"What inspires me about my new role at Stemedica is the opportunity to expand and improve manufacturing systems and processes in a cutting edge environment like the one offered at Stemedica. I am eager to bring my detailed knowledge and experience in building new manufacturing capabilities to Stemedica as they transition from research and development into full scale manufacturing. The set-up of first-time manufacturing is complex and it is an exciting prospect to work with the great minds here at Stemedica. Together, we will create the means to extend the benefits of stem-cell research and therapies to an ever widening audience", said Mr. Bullen.

Mr. Bullen will report directly to Dr. Alex Kharazi, Vice President of Medical Research at Stemedica. "The appointment of Carl Bullen is a significant step in our progress towards supporting clinical trials of our products in the United States and other locations around the world. As we complete the final steps in the certification process with California's Food & Drug Board and evolve toward the manufacturing of allogeneic clinical grade product for external clients as well as for our own clinical trials, it is fundamental to have someone of Carl's biomedical manufacturing expertise working for the organization", said Dr. Kharazi.

About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies Inc. (http://www.stemedica.com) is a specialty biopharmaceutical company that is committed to the development and manufacture of best-in-class adult stem cells for use by approved research institutions and hospitals for pre-clinical and clinical studies. Within the United States, the Company is currently developing regulatory pathways for stroke, traumatic brain injury and wound repair. Outside the United States, Stemedica provides its adult stem cells to hospitals and research centers that are conducting studies under protocols approved by the appropriate regulatory agencies. These studies are focused on the treatment of neurodegenerative disease, sight restoration and wound repair. Stemedica is based in San Diego, California.

Media Contact for Stemedica: Dave McGuigan at dmcguigan (at) stemedica.com.

CIRM Completes Briefing Visit to Stemedica Cell Technologies

2009-03-02T00:01:00.000-08:00

San Diego, California (STEMEDICA) March 2, 2009 -- Leadership of the California Institute for Regenerative Medicine ("CIRM") completed a two part visit to Stemedica Cell Technologies, Inc. ("Stemedica") to tour its manufacturing facility, R&D lab and corporate headquarters.

Left to Right: Dr. Kharazi, Dr. Lipton,
Robyn Garcia (Stemedica Quality Control Director),
Dr. Tankovich, Dr. Trounson
Originally uploaded by Stemedica

"I was glad to have the opportunity to visit Stemedica and get to know more about its leadership, plans for the future and to see first hand the assets and potential they represent to the stem cell movement in California", said Dr. Alan Trounson, President of CIRM. "We want to have strong working relationships with all sectors of California's stem cell industry, including for-profit companies like Stemedica."

Prior to Dr. Trounson's visit, Dr. Marie Csete, CIRM's Chief Scientific Officer had the opportunity to visit Stemedica's manufacturing facility and R&D laboratory. "We're delighted to see Stemedica make the effort to secure a clinical grade manufacturing license from the State of California. We believe this capability will aid numerous organizations in California and around the world in their efforts to manufacture stem cell products for clinical application", said Dr. Csete.

"We were pleased to have Dr. Trounson and Dr. Marie Csete visit our facilities and receive a briefing from our leadership", said Dr. Maynard Howe, Stemedica's Vice Chairman & CEO. "We continue to play a pivotal role in the evolution of the stem cell industry in California and believe a supportive working relationship with CIRM is an essential part of this process.

Stuart Lipton, M.D., Ph.D., Scientific Director and Senior Vice President of the Del E. Webb Center for Neuroscience, Aging and Stem Cell Research at the Burnham Institute for Medical Research, San Diego, CA, joined Dr. Trounson during his visit to Stemedica's manufacturing facility. "I was impressed with the progress that Stemedica has made on the licensing process for clinical grade allogeneic stem cell manufacturing and am excited about expanding our research relationship with the Stemedica team. Having a manufacturing resource like this in California will be a great asset to our entire research community. I anticipate that many CIRM-funded stem cell research institutions will take advantage of Stemedica's manufacturing facility that will soon become FDB (Food & Drug Board) cGMP licensed."

Dr. Nikolai Tankovich, Stemedica's President and Chief Medical Officer organized the visits for Dr. Trounson, Dr. Csete and Dr. Lipton. "We're delighted that these outstanding leaders within California's stem cell movement took the time to find out more about Stemedica and our plans to lead this industry from a manufacturing standpoint. We will continue to seek the wise counsel of CIRM in an effort to align our efforts with theirs. In addition, we are expanding our collaborative research efforts with the Burnham Institute for Medical Research and several other California stem cell research institutions", said Dr. Tankovich.

About Stemedica Cell Technologies, Inc.:
Stemedica Cell Technologies Inc. (http://www.stemedica.com) is a specialty biopharmaceutical company that is committed to the development and manufacture of best-in-class adult stem cells for use by approved research institutions and hospitals for pre-clinical and clinical studies. Within the United States, the Company is currently developing regulatory pathways for stroke, traumatic brain injury and wound repair. Outside the United States, Stemedica provides its adult stem cells to hospitals and research centers that are conducting studies under protocols approved by the appropriate regulatory agencies. These studies are focused on the treatment of neurodegenerative disease, sight restoration and wound repair. Stemedica is based in San Diego, California.

About CIRM:
The California Institute for Regenerative Medicine (CIRM) was established in 2005 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure, which provided $3 billion in funding for stem cell research at California universities and research institutions, was overwhelmingly approved by voters, and called for the establishment of an entity to make grants and provide loans for stem cell research, research facilities, and other vital research opportunities. To date, the CIRM governing board has approved 229 research and facility grants totaling more than $614 million, making CIRM the largest source of funding for human stem cell research in the world. For more information, please visit http://www.cirm.ca.gov.

Media Contact for Stemedica: Dave McGuigan at dmcguigan (at) stemedica.com.

Stemedica Medical Team Cautions Patients About Stem Cell Therapy & Comments on PLoS Medicine Article

2009-02-27T00:01:00.000-08:00

SAN DIEGO, California. (February 27, 2009) Stemedica Cell Technologies, Inc. (“Stemedica”) provided its observations and comments to the media regarding the PLoS Medicine article published online February 17, 2009. The PLoS Medicine article describes a patient who developed “brain tumors” (glioneuronal neoplasms) after undergoing repeated transplants of “fetal neural stem cells” in Russia starting in 2001.

“All of us at Stemedica would like to extend our condolences to the young patient involved in this situation and our hope is for a speedy and positive outcome to this unfortunate experience. Never before have we or any of our Principal Investigators ever encountered such an occurrence either in our own research or in any of the published research”, said Dr. David Howe, Stemedica’s Vice President and Medical Director.

“We want to use this unfortunate incident to warn those seeking stem cell therapy abroad,” warns Dr. Nikolai Tankovich, President & Chief Medical Officer of Stemedica, “to make certain that the manufacturer of the stem cells used in transplantation comply with the rigid standards that have been established by the FDA and other Internationally-recognized regulatory agencies. The future of this industry and the safety of all future patients depend on such adherence.” FDA Compliance and Surveillance Standards can be referenced by visiting www.fda.gov/cber/compliance.htm.

The report in PLoS, Donor-Derived Brain Tumor Following Neural Stem Cell Transplantation in an Ataxia Telangiectasia Patient, describes the development of multifocal glioneuronal neoplasms along the spinal nerves and brain stem in a 13-year-old patient who underwent repeated transplantation procedures in an attempt to treat ataxia-telangiectasia (A-T). A-T is a progressive neurodegenerative disorder known to have an increased risk of developing cancer.

Malignancy and neoplasia are common in A-T secondary to deficient cellular and humoral immunity. This immune deficiency is a contra-indication to stem cell transplant therapy. In addition, the mutations associated with A-T in the A-T mutation gene lead to mutations in nuclear protein, which normally repairs DNA. This loss of DNA repair combined with immune deficiency in A-T increases risk of neoplasia with and without cellular transplant therapy in A-T.

“Due to age, children and adolescents have significantly increased quantities of growth factors. Adding stem cells, known for their growth factor production capabilities, to a child with this presenting condition may have been a contributing factor. As in the administration of pharmaceuticals, many of which are not recommended for use in children and adolescents in the same way as in treating adults, great care must be taken in using stem cell therapy with this population of patients”, said Dr. Michael Bayer, Stemedica’s Director of Medical Services.

Based on the facts and references cited within the PLoS Medicine article, researchers have discovered that some of the cells were female and had two copies of the gene that causes A-T. Karyotype testing was reported in this case which confirms inadequate testing of the stem cells prior to transplantation. “The stem cell preparation protocol provided to the parents by the treatment team was reviewed and found to be inadequate by our standards”, said Dr. Howe. “No cell characteristics, cell markers or bio-safety data was present. Mechanical desegregation in the 8-12 week age fetus is not recommended. Enzymatic separation is preferred, a process that also removes any dead cells that may be present. There is also a significant lack of detail on the number of cell passages as well as the dispersion of the neurospheres”, Dr. Howe went on to say.

Dr. Alex Kharazi, Stemedica’s Vice President for Manufacturing & Research observed, “Limited cell culturing in only 12-16 days as described in their protocol is like using a crude primary culture of cells. There are numerous risks associated with using crude cell preparations that have not been subjected to rigid manufacturing and testing protocols such as purity, identity and potency. In addition, the antibiotics used to manufacture the stem cells, are potentially neurotoxic.” Dr. Kharazi went on to say, “Overall the description provided for the manufacturing protocol was vague and a poor example of what a well thought out manufacturing and safety-driven process should be. For example, there was no data provided relating to tumorgenicity, toxicity, or bio-distribution testing of the manufactured cells in nude mice which is a mandatory requirement as a first and critical step to assessing cell safety.”

“Stemedica is committed to a manufacturing process that puts safety first at all times. Our stem cell product lines go through extensive testing during several stages of the manufacturing process and are also subjected to in-depth pre-clinical studies before filing with the FDA and other regulatory agencies for clinical trials”, continued Dr. Kharazi. “Nothing is more important than the welfare of the patient and there is no explanation that can justify any deviance from compliance to FDA guidelines for the manufacturing and testing of stem cells prior to administration. These are the guidelines we follow and any patient considering stem cell therapy, at any location worldwide, should confirm that the manufacturer is in full compliance before they decide to undergo stem cell transplantation.” warns Dr. Kharazi.

About Stemedica Technologies, Inc.
Stemedica Cell Technologies Inc. (www.stemedica.com) is a specialty biopharmaceutical company that is committed to the development and manufacture of best-in-class adult stem cells for use by approved research institutions and hospitals for pre-clinical and clinical studies. Stemdedica complies with the standards and guidelines established by the FDA and the FDB (Food and Drug Board) in the manufacturing and testing of its stem cells. Within the United States, the Company is currently developing regulatory pathways for stroke, traumatic brain injury and wound repair. Outside the United States, Stemedica provides its adult stem cells to hospitals and research centers that are conducting studies under protocols approved by the appropriate regulatory agencies. These studies are focused on the treatment of neurodegenerative diseases, sight restoration and wound repair. Stemedica is based in San Diego, California.

Media Contact for Stemedica: Dave McGuigan at dmcguigan@stemedica.com.

Stemedica files with Food & Drug Branch of State of CA Dept. of Public Health for cert. as a licensed Mfr of Adult Stem Cells for US Clinical Trials

2009-02-25T00:01:00.000-08:00

Feb 25, 2009 – Stemedica Cell Technologies, Inc. ("Stemedica") announced today that it has filed with the Food and Drug Branch of the State of California's Department of Public Health for certification as a licensed manufacturer of adult stem cells for U.S.-based Phase I and Phase II Clinical Trials. Readiness for manufacture includes obtaining a California Drug Manufacturing License for the Stemedica facility in San Diego, California.

"Completion of this certification will allow us to manufacture stem cells under contract for clinical trials for Stemedica as well as for other companies and research centers in California and across the United States. This marks a significant milestone along the journey toward the future availability of stem cell treatment for patients who so urgently need it," said Dr. Maynard Howe, Vice Chairman and CEO at Stemedica.

To prepare for inspection, Stemedica fully reconstructed its facility according to FDA requirements, which had previously focused on research and development. Stemedica's manufacturing facility now includes a fully compliant manufacturing wing with entry-level gowning rooms, two ISO class 8 sterile gowning suites, an ISO Class 7 Manufacturing Clean Room, an ISO Class 7 Processing Clean Room, a Good Manufacturing Process compliant materials warehouse and a controlled-access Quality Control testing laboratory.

"As soon as Stemedica secures its license from the State of California's Department of Public Health, we plan on filing for one or more IND's (Investigative New Drug) for specific indications with the FDA using our proprietary technology. The final major step by the Food and Drug Branch within the Department of Public Health is an in-depth, in-person inspection by their personnel. We're particularly proud of the fact that we are ready for, and capable of, seeking licensing in California, which has exceptionally stringent standards," said Dr. Alex Kharazi, Vice President, Research & Manufacturing at Stemedica.

"Becoming a Licensed Manufacturer of clinical grade adult stem cells is a significant scientific and medical step forward for the Company," said Dr. Nikolai Tankovich, Stemedica's President and Chief Medical Officer. "Securing this status will allow us to become a primary CMO (Contract Manufacturing Organization) for other for-profit companies and the many research organizations interested in advancing stem cell research through clinical application. Additionally, achieving this regulatory status within the manufacturing world will provide Stemedica with the foundation to advance its own Phase I and Phase II Clinical Studies once approved by the FDA."

About Stemedica Technologies, Inc.
Stemedica Cell Technologies Inc. (http://www.stemedica.com) is a specialty biopharmaceutical company that is committed to the development and manufacture of best-in-class adult stem cells for use by approved research institutions and hospitals for pre-clinical and clinical studies. Within the United States, the Company is currently developing regulatory pathways for stroke, traumatic brain injury and wound repair. Outside the United States, Stemedica provides its adult stem cells to hospitals and research centers that are conducting studies under protocols approved by the appropriate regulatory agencies. These studies are focused on the treatment of neurodegenerative disease, sight restoration and wound repair. Stemedica is based in San Diego, California.

Media Contact for Stemedica: Dave McGuigan -- dmcguigan (at) stemedica.com.

Stemedica Announces the Appointment of Riccardo Nisato, MBA, PhD as Director of Manufacturing and Clinical Business Dev. for Stemedica Internatational

2009-02-15T11:20:00.000-08:00

Feb 13, 2009 – Stemedica Cell Technologies, Inc., a leader in adult stem cell development, today announces that it has appointed Riccardo Nisato, MBA, PhD, as Director of Manufacturing and Clinical Business Development of Stemedica International, CH. Dr. Nisato will be responsible for replicating Stemedica's U.S. based operations to Stemedica's International's center based in Lausanne, Switzerland.

A respected biologist, project leader and business consultant in the medical technology field, Dr. Nisato's specialty is the development of strategic options for cell therapy manufacturing that complies with Swiss Medic standards for Good Manufacturing Practice (GMP) in Switzerland. Dr. Nisato has a Master in Pharmacology from the University Paris V, a Ph.D. in Biology from the University of Geneva and an MBA in the Management of Technology from École Polytechnique Fédérale de Lausanne (EPFL), Lausanne, Switzerland.

"We are delighted to add Dr. Nisato to our Stemedica International team. Our plans to serve Clinical Research Centers outside the United States with in-depth stem cell research, product development, manufacturing and Master Bank product capabilities will be significantly advanced by Dr. Nisato's leadership and experience. His expertise in the cell manufacturing processes, including his intimate interaction with researchers and clinicians involved in Phase I, Phase II studies and approved treatments derived from fetal and adult cells, combined with his years of consulting for medical technology companies will provide invaluable direction for our international development strategy," said Roger Howe, Chairman and CFO at Stemedica.

"The prospect that Stemedica International represents for establishing regulatory-approved clinical trials at high-accredited treatment facilities around the world, leading to successful treatment for patients with debilitating conditions, is an invigorating opportunity for me at this point in my career. I have been fortunate to extensively collaborate with researchers and surgeons involved in cell-based clinical trials and approved therapies for skin burn treatments for children and adults, so I am intimately aware of the difference that Stemedica International will make in the future. It's an honor to be in at ground level, working to build Stemedica into a worldwide leader in the adult stem cell industry," said Dr. Nisato.

Dr. Nisato will report to Dr. Alex Kharazi, Vice President, Research & Manufacturing for Stemedica International's partner organization, Stemedica Cell Technologies and to Dr. Nikolai Tankovich, Chairman of Stemedica International and President and Medical Officer of Stemedica Cell Technologies.

"Dr. Nisato has the perfect combination of medical knowledge in pharmacology and cell biology as well as with medically-oriented business development that makes him the perfect choice for this significant new role. We are very fortunate to have attracted his interest and to have brought about this significant appointment. I am excited about extending our solid U.S. work to Europe under Dr. Nisato's strategic oversight," said Dr. Tankovich.

As posted to PRlog & PRWeb & Stemedica.com

Stemedica Announces the Appointment of Dr. Michael Bayer as Director, Medical Services

2009-01-30T00:01:00.000-08:00

San Diego, CA -- Stemedica Cell Technologies, Inc., a leader in adult stem cell production, announced today the appointment of Michael Bayer, MD, as Director, Medical Services. Dr. Bayer will be responsible for developing pre-clinical and clinical trial protocols for use by research centers conducting pre-clinical and clinical trials using Stemedica products.

An Orthopedic Surgeon and Clinician, Dr. Bayer's specialty is Translational Medicine - taking laboratory research and results and applying them in new patient treatments. World renowned for inventing an arthroscopic surgical technique for repairing rotator cuff injuries, Dr. Bayer has worked with major clinical research institutions and physicians around the world to bring new technology safely and successfully into the medical marketplace.

Dr. Bayer's new role at Stemedica was warmly welcomed by Dr. Nikolai Tankovich, President, Chief Medical Officer of Stemedica. "I am very impressed with Dr. Bayer's long track record of translating laboratory results to practical surgery and treatments. Dr. Bayer is a brilliant surgeon and clinician and we feel very fortunate to have attracted his interest and to have brought about this significant appointment. I am looking forward to working with him to advance our work," said Dr. Tankovich.

For the past year, Dr. Bayer has been involved in a Fellowship Study Program with Dr. Nikolay Mironov, the world's foremost adult stem cell clinician, and with Dr. Alex Kharazi, Stemedica's Vice President - R&D and Manufacturing.

"My interest in Stemedica and their technology quickly deepened when I became aware of the difference that treatments were having on the quality of life for patients participating in clinical trials. After a year of study and interaction with Drs. Mironov and Kharazi, I believe I have as strong a knowledge of stem cell effects in research and medical applications. I was so inspired by what I had learned and witnessed first hand from clinical outcomes of patients participating in overseas clinical studies that I asked Stemedica if there was any way I could support the company with my translational knowledge and experience. In my new role, I know I will be making a difference in a very important and evolving area of medicine. That really matters to me," said Dr. Michael Bayer.

"We realized from the first day we met Dr. Bayer that he had the experience in medical technology innovation and in translational medicine that would be valuable to a company like ours. After his fellowship with Drs. Mironov and Kharazi we knew he had the commitment and first hand knowledge to support the ongoing development of our pre-clinical and clinical trials treatment protocols. We created the role for Dr. Bayer based on his interest in working with us and his desire to impact the quality of life possibilities for no-option patients. Stemedica is delighted to have Dr. Bayer join our team," said Maynard Howe, CEO and Vice Chairman at Stemedica.

In addition to his professional work, Dr. Bayer co-founded "The Free Wheelchair Mission", a non-profit that has delivered wheel chairs to over 370,000 people in some of the poorest countries worldwide. (www.freewheelchairmission.org)

About Stemedica Cell Technologies, Inc.

Stemedica Cell Technologies Inc. (http://www.stemedica.com) is a specialty biopharmaceutical company that is committed to the development and manufacture of best-in-class adult stem cells for use by approved research institutions and hospitals for pre-clinical and clinical studies. Within the United States, the Company is currently developing regulatory pathways for stroke, traumatic brain injury and wound repair. Outside the United States, Stemedica provides its adult stem cells to hospitals and research centers that are conducting studies under protocols approved by appropriate regulatory agencies. These studies are focused on the treatment of neurodegenerative disease, sight restoration and wound repair. Stemedica is headquartered in San Diego, California.

From more information regarding Stemedica Cell Technologies or the Dr. Michael Bayer appointment, contact Dave McGuigan at dmcguigan (at) stemedica (dot) com.

As posted to PRlog & PRWeb & Stemedica.com

Adult Stem Cell Images created by Stemedica Labs

2009-01-27T10:02:00.001-08:00

Epithelial
Originally uploaded by Stemedica

If you head over to the Stemedica web site - take a look at the banner images on the top of every page. Those images are real stem cell images produced by the scientists who are conducting research on adult stem cell manufacturing at Stemedica Labs. These ones happen to have been captured from research conducted at our start-of-the-art Lab in San Diego,CA that has been designed from the ground up to be cGMP compliant.

More images like these are available by visiting the Stemedica Photostream on Flickr

Dr Nabil Dib takes on Special Advisor role to the Stemedica Board of Directors

2009-01-26T00:01:00.000-08:00

San Diego, CA (Stemedica) January 26, 2009 — Stemedica Cell Technologies, Inc. announces leading stem cell specialist Dr Nabil Dib, MD as Special Advisor to its Board of Directors. Dr Dib is President of the International Society for Cardiovascular Translational Research (ISCTR) and Director of Cardiovascular and Stem Cell Consultants (CSCC).

“In looking for someone to serve as Special Advisor to the Board, we sought a medical leader who had practical experience in working with the FDA and the research community in advancing therapeutic stem cell solutions. We feel fortunate to have secured an Advisory Relationship with a true leader within the stem cell industry. Dr. Nabil Dib has as much extensive research, regulatory and clinical application experience with adult stem therapy as anyone in the United States,” said Nikolai Tankovich, MD, PhD, President & Chief Regulatory and Medical Officer of Stemedica.

In accepting the role of Special Advisor, Dr Dib said, “I’m honored to be associated with Stemedica Cell Technologies. As someone who strives to help build this industry, my research tells me that Stemedica stands out as a leader within our sector. Many stem cell research and manufacturing companies make significant progress in the laboratory, but what distinguishes Stemedica is the extent of their clinical research experience.”

“With Dr. Dib we get an independent minded, diligent investigator who has the hands on proven experience in advancing stem cell research and technology from bench top to bed side with the highest possible concern for the safety of the patient and the efficacy of the application,” said Maynard Howe, PhD, Vice Chairman and CEO for Stemedica.
About Stemedica Technologies, Inc.

Stemedica Cell Technologies Inc. (http://www.stemedica.com/) is a specialty biopharmaceutical company that is committed to the development and manufacture of best-in-class adult stem cells for use by approved research institutions and hospitals for pre-clinical and clinical studies. Within the United States, the Company is currently developing regulatory pathways for traumatic brain injury and wound repair. Outside the United States, Stemedica provides its adult stem cells to hospitals and research centers that are conducting studies under protocols approved by the appropriate regulatory agencies. These studies are focused on the treatment of neurodegenerative disease, sight restoration and wound repair. Stemedica is based in San Diego, Calif.

For more information regarding Stemedica Cell Technologies or the Dr Nabil Dib appointment, contact Dave McGuigan at dmcguigan@stemedica.com.

As posted to PRWEB news wire: Dr Nabil Dib Takes on Special Advisor Role to the Stemedica Board of Directors

STEMEDICA CELL TECHNOLOGIES & GYEONGGI PROVINCE, KOREA JOIN FORCES

2008-06-18T14:46:00.000-07:00

(Source: June 2008; Stemedica Cell Technologies, Inc.) View video of the event>>>

Leaders from Stemedica Cell Technologies (Stemedica), a San Diego-based adult stem cell research and development company, and the Gyeonggi Province, Republic of Korea’s government, gathered in Palo Alto, California to sign a Memorandum of Understanding that will stimulate economic development and technological advancement between the parties.

“This is an important relationship for the Gyeonggi Province.” said Governor Moon-Soo Kim, “We are delighted to have Stemedica’s experience and expertise invested in our Province and country, and we are ready to help them build their Korean investment into a regional success story.” The Gyeonggi Province is the largest province in the Republic of Korea, with Seoul as the Province’s largest city.

“This Memorandum will allow Stemedica to bring our adult stem cell research and know-how to Korea while, at the same time, providing our organization with a wealth of intellectual and organizational resources. We are very pleased with this agreement between Stemedica and the Province.” said Roger J. Howe, PhD, Executive Chairman of Stemedica.

Stemedica’s commitment includes the completion and hiring of area residents for its new laboratory and manufacturing facility located in the Province’s Ahn San Techno Park. “The Memorandum outlines a commitment by the Governor of the Province to introduce and otherwise help develop academic, regulatory, corporate and funding relationships for Stemedica”, said Maynard A. Howe, PhD, CEO & Vice Chairman of Stemedica. “The Governor’s strong and pro-active support will provide significant value to Stemedica as we work to establish our presence in Korea and across the Asian Pacific region.”

The event was attended by a delegation from the Gyeonggi Province, international media and Stemedica leadership including CEO and Vice Chairman Maynard A. Howe, PhD, Executive Chairman Roger Howe and Board Members William Maloney, MD (Professor and Chairman of the Department of Orthopaedic Surgery Stanford University) and Neil Kurtz, MD, (CEO of TorreyPines Therapeutics).

For more information regarding this Media Release or Stemedica Cell Technologies, contact Dave McGuigan at dmcguigan@stemedica.com.

Stemedica and Hospital Angeles announce partnership

2007-09-13T14:52:00.000-07:00

Source: September 2007; Stemedica Cell Technologies, Inc.)

Stemedica Cell Technologies announced at a media conference September 13th that it has established a partnership with Hospital Angeles-Tijuana, part of Grupo Angeles Servicios de Salud, the largest private hospital group in Mexico. Hospital Angeles will provide adult stem cell treatments under strict clinical study protocol to patients afflicted with specific medical conditions associated with Alzheimer’s, Parkinson’s, Multiple Sclerosis, Muscular Dystrophy, Stroke, Ischemic Brain Trauma, Spinal Cord Injury and other neurodegenerative conditions and diseases.

At the conference, Maynard Howe, Ph.D, CEO and Vice-Chairman of Stemedica, explained that Stemedica was formed when a relative was seriously injured in a car accident. The family began to explore various treatments for spinal cord injuries and discovered that Russia had been developing stem cell technology for over 30 years. The relative, who was a quadriplegic, has undergone two treatments in Russia. Since then, she has regained the use of her upper body and is now learning to walk again, as she demonstrated for the audience at the media conference.

According to Dr. Howe, the partnership with Hospital Angeles - Tijuana is an exciting opportunity to work with the leading hospital chain in Mexico. “Hospital Angeles is a state of the art facility providing the highest level of care.”

At the conference, Dr. Cesar Amescua, the hospital’s medical director, gave an in-depth presentation regarding patient treatments using adult stem cells. Dr. Amescua said “We expect to demonstrate the safety and efficacy of adult stem cell treatments in patients through use of Stemedica’s innovative technology. We will advance these treatments following a strict Clinical Study Protocol as approved by our Ethics and Internal Review Board Committees.”

Stemedica is in the process of interviewing a number of highly-accredited treatment facilities that may eventually become Clinical Research Centers where adult stem cell therapy using Stemedica International product can take place under regulatory-approved Clinical Study Protocols.