(Source: October 2, 2012; Stemedica Cell Technologies, Inc., San Diego CA)
Stemedica Cell Technologies, Inc., a leader in adult allogeneic stem cell manufacturing, research and development, announced today that the U.S. Food and Drug Administration (FDA) approved its application for an Investigational New Drug (IND) to assess the clinical effects of StemedyneMSC (Stemedica’s human bone marrow-derived ischemia tolerant mesenchymal cells) in subjects with a myocardial infarct. The Phase IIa doubleblinded randomized clinical trial will study approximately forty (40) patients. All patients will initially receive standard care including percutaneous transluminal coronary angioplasty (PTCA) and stenting and, upon completion, will be randomized to receive StemedyneMSC intravenously or placebo.
The clinical trial will address the prevalence of cardiovascular disease estimated to carry a global disease burden in excess of $400 billion each year. More than one million patients undergo PTCA and stenting in the United States annually; another 800,000 have the procedures each year in Europe.
Nabil Dib, M.D., MSc., F.A.C.C., Director of Cardiovascular Research at Mercy Gilbert and Chandler Regional Medical Centers, and an Associate Professor of Medicine and Director of Clinical Cardiovascular Cell Therapy at the University of California, San Diego, will serve as the principal investigator of the FDAapproved study. Dr. Dib commented, "We’ve learned from bench top research that not all stem cells are created equally. We believe that the ischemic tolerance of Stemedica’s MSCs and the robustness of their protein array will translate into significant patient benefits post myocardial infarction."
Stemedica’s interest in this indication was triggered by a successful randomized study in acute myocardial infarction conducted by the National Scientific Medical Center (NSMC) in Astana, Kazakhstan using StemedyneMSCs. The study was conducted under clinical protocol and in compliance with the ICHE6 (Good Clinical Practice) guidelines and local laws. All patients signed an informed consent. Nineteen (19) patients in this study received StemedyneMSCs after PTCA and stenting. Administration of StemedyneMSC resulted in a statisticallysignificant decrease in inflammation as judged by the level of Creactive protein, significant decrease in endsystolic and end-diastolic volume of left ventricle, as well as significant increase in the left ventricular ejection fraction (LVEF) from 38.4% to 54.7% at 6 months post administration, bringing this parameter to a normal range for healthy individuals (5065%).
Professor Daniyar Jumaniyazov, M.D. Ph.D., principal investigator of the NSMC study commented, "The stem cell transplantation was safe and the procedure was well tolerated. No product-related adverse events were reported. Treatment of patients in this study resulted in improvement of overall and local contractive myocardium functions and also normalization of systolic and diastolic filling of the left ventricle as compared to the control group. Based upon the safety and efficacy results, we will soon conduct a Phase III myocardial infarct clinical trial at the NSMC with Stemedica’s ischemia tolerant mesenchymal stem cells."
Lev Verkh, Ph.D., Stemedica Chief Regulatory and Clinical Development Officer commented, "Stemedica&rss FDA submission included data from the NSMC clinical trial, the results of which were also reported at the annual American College of Cardiology meeting in April, 2012. These results contrasted with reports, at the same conference, of minimal improvement in studies with autologous stem cells. In addition to the United States sites, the study will be duplicated at leading hospitals in Europe, Asia and the Middle East." With regard to the spectrum of stem cell treatment for cardiovascular disease, Dr. Verkh noted that, "StemedyneMSC has been approved for the treatment of chronic heart failure at Hospital Angeles, Tijuana, Mexico by COFEPRIS (the Mexican equivalent of the FDA).
Jackie See, M.D., F.A.C.C., founder of interventional cardiology at the University of California, Irvine, noted, "In the days and weeks following a myocardial infarction we may have the ability to intervene with stem cells to minimize scarring, enhance the amount of functional heart tissue, and restore the microcirculation. Stemedica’s ischemia tolerant mesenchymal stem cells are ideal for this purpose. I can foresee the day when all coronary stenting is accompanied by stem cell injection. It is not unreasonable to postulate that the antiinflammatory and antifibrotic effects of the mesenchymal stem cells may have an impact on the incidence of restenosis, a common condition caused by blockage of the stents."
The StemedyneMSC product is uniquely manufactured to contain increased amounts of the important growth factors that combat ischemic damage. According to Nikolai Tankovich, M.D., Ph.D., President and Chief Medical Officer of Stemedica, "Our ischemia tolerant MSCs secrete increased amounts of vascular endothelial growth factor (VEGF), which is necessary for new blood vessel development and stromal cellderived factor (SDF), which is responsible for rescuing dying cells. StemedyneMSCs also demonstrate significantly higher migratory abilities. As a company we are unique in our unparalleled scalability, with our master bank at two passages and the cells that go into patients having only been expanded four times. We have the ability to treat more than 500,000 patients with cells created from a single organ donation."
StemedyneMSC is one of the three adult allogeneic stem cell products developed by the Company. Other products include StemedyneNSC neural human stem cells and StemedyneRPE, retinal progenitor epithelial cells available in early 2013. All Stemedica products are unique in their ability to tolerate ischemic conditions.
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 preclinical and clinical (human) trials. The company is a government licensed manufacturer of clinical grade stem cells and is approved by the FDA for clinical trials in ischemic stroke, cutaneous photoaging and STEMI. Stemedica is currently developing regulatory pathways for a number of other medical indications using adult allogeneic stem cells. The company is headquartered in San Diego, California.
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