Thursday, November 17, 2016
Positive Results From Study Sponsored by CardioCell Post in the American Heart Association’s Journal “Circulation Research”
Peer-Reviewed Paper Details First Completed Phase IIa Clinical Trial Using Intravenous (IV) Administration of Mesenchymal Stem Cells (MSCs) for Chronic Heart Failure Indications
SAN DIEGO — Nov. 17, 2016 — Results from a study sponsored by CardioCell LLC, a global biotechnology company that uses allogeneic stem cells for cardiovascular indications, form the basis for a peer-reviewed paper published in the American Heart Association’s journal “Circulation Research.” Entitled “Intravenous (IV) Allogeneic Mesenchymal Stem Cells for Non-Ischemic Cardiomyopathy: Safety and Efficacy Results of a Phase II-A Randomized Trial,” the paper authors include CardioCell’s Scientific Advisory Board members Drs. Stephen E. Epstein, Arshed A. Quyyumi, Mihai Gheorghiade and Javed Butler, as well as board directors Sergey Sikora, Ph.D., and Nikolai I. Tankovich, M.D., Ph.D. Additional authors include Stephen J. Greene, Raymond J. Kim, Allen S. Anderson, Jane E. Wilcox, Michael J. Lipinski, Yi-an Ko, Kenneth B. Margulies, Robert T. Cole and Hal A. Skopicki.
“It is an honor to have CardioCell’s positive Phase IIa clinical trial results included in a ‘Circulation Research’ paper,” says Sergey Sikora, CEO of CardioCell and paper co-author. “Based on the promising findings, we are currently developing larger studies based on IV delivery of our ischemia-tolerant mesenchymal stem cells (itMSCs) for heart failure indications, including both non-ischemic and ischemic cardiomyopathy.”
Available online via subscription or for purchase, the paper explores the safety of IV itMSC administration and whether “Potential benefits of mesenchymal stem cell (MSC) therapy in heart failure (HF) may be related to paracrine properties and systemic effects, including anti-inflammatory activities. If this hypothesis is valid, IV administration of MSCs should improve outcomes in HF, an entity in which excessive chronic inflammation may play a pivotal role.” Study results showed statistically significant improvement in 6-minute walk test, quality-of-life scores as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) and favorable immune modulatory benefits. The article concludes, “In this pilot study of patients with non-ischemic cardiomyopathy, itMSC therapy was safe, caused immunomodulatory effects, and associated with improvements in health status and functional capacity.”
Featured in this clinical trial, CardioCell’s therapies use itMSCs, which are exclusively licensed from Stemedica. Unlike MSCs grown under normoxic conditions, bone-marrow-derived, allogeneic itMSCs are grown under hypoxic conditions. In vivo experiments demonstrate cells that are exposed to hypoxic conditions show greater homing and engraftment than cells grown under normoxic conditions. Compared to MSCs manufactured under normal oxygen condition, itMSCs secrete higher levels of growth factors and other important proteins associated with neoangiogenesis and healing.
Founded in San Diego, California, in 2013, CardioCell LLC is a global biotechnology company that explores therapeutic applications of unique, patented, ischemia-tolerant mesenchymal stem cells manufactured under cGMP conditions. CardioCell is a subsidiary of Stemedica Cell Technologies Inc., a global biotechnology company that manufactures adult allogeneic stem cells. The company’s technology is based on more than 30 years of research and clinical experience conducted by scientists and physicians in the United States, Europe and the former Soviet Union. CardioCell therapies offer a unique, proprietary technology based on the expansion of cells in constant hypoxia. The company has an exclusive, worldwide license from Stemedica to explore therapeutic indications for unmet cardiovascular needs, such as acute myocardial infarction, chronic heart failure and peripheral artery disease. For more information, visit www.stemcardiocell.com.