Peer-Reviewed Publication Reports on Medistem’s Ongoing Phase II Trial
SAN DIEGO, CA–(Marketwire – Mar 22, 2013) – Medistem Inc. ( PINKSHEETS : MEDS ) announced today it published an update on its RECOVER-ERC congestive heart failure Phase II clinical trial in a peer-reviewed journal (link to paper http://www.translational-medicine.com/content/pdf/1479-5876-11-56.pdf). The publication reports safety of its proprietary stem cell population, termed “Endometrial Regenerative Cells” (ERC), as well as data supporting the patent-pending 30 minute catheter-based retrograde delivery technique through which the stem cells are administered.
“To date, all stem cell trials in the cardiac space use bone marrow and adipose tissue sources. Unlike the painful and highly invasive process of collecting bone marrow and adipose stem cells, our collection processes involves extraction of a small amount of menstrual blood from young healthy donors. In our FDA-cleared manufacturing protocol, one donor generates 20,000 doses,” said Alan Lewis, Ph.D., Chief Executive Officer of Medistem. “ERC are administered without tissue matching or the requirement for immune suppressive drugs. Our product is delivered to the point-of-care as a cryogenically preserved allogeneic therapy that is ready to use, without need for end user manipulation. This feature could make it practical for clinicians to efficiently deliver stem cell therapy to large numbers of heart failure patients.”
“This is the first time that the minimally-invasive catheter-based retrograde delivery technique has been used in the context of a ‘universal donor’ stem cell,” said Amit N. Patel, M.D., Director of Cardiovascular Regenerative Medicine at the University of Utah and the senior author of this publication. “The delivery technique used in the current study can be widely performed by any licensed interventional cardiologist with minimal training. This is in contrast to other stem cell delivery techniques that require extensive user training and complex equipment that is not readily available.”
The RECOVER-ERC trial is a 60 patient, double-blind, placebo controlled study in which patients with congestive heart failure are divided into 3 groups, which receive ERC in a dose escalating manner of 50, 100,and 200 million cells. Main efficacy endpoints are at 6 months after treatment with safety endpoints assessed up to one year.
To date, 17 patients have been treated with no treatment associated adverse events reported. The Principle Investigator is Leo Bockeria, M.D., Chairman of the Bakoulev Center and Academician of the Russian Academy of Science. The Bakoulev Center is Russia’s premier institute for cardiovascular surgery and cardiology. Every year the Backulev Center performs approximately 30,000 procedures including 7,000 open heart surgeries and more than 12,000 angioplasties.
Amit Patel, M.D., is the International Principle Investigator for the trial and was the first physician to administer stem cells into the human heart.
Safety oversight for the trial is performed by the independent Data Safety Monitoring Board (DSMB) which is chaired by Warren Sherman, M.D., Director of Cardiac Cell-Based Endovascular Therapies at Columbia University.