Tuesday, April 19, 2016
CardioCell Completes Enrollment for a Phase IIa Clinical Trial Using Its Stem Cells for Participants With Chronic Heart Failure
SAN DIEGO — April 19, 2016 — CardioCell LLC, a global biotechnology company that uses allogeneic stem cells for cardiovascular indications, fulfills enrollment for its Phase IIa chronic heart failure (HF) clinical trial. A total of 23 randomized participants were enrolled at study centers at Emory University in Atlanta, MedStar Washington Hospital Center in Washington, D.C., Northwestern University in Chicago, Stony Brook University on Long Island and the University of Pennsylvania in Philadelphia. The study, entitled “Single-blind, Placebo-controlled, Crossover, Multi-center, Randomized Study to Assess the Safety, Tolerability and Preliminary Efficacy of a Single Intravenous Dose of Ischemia-tolerant Allogeneic Mesenchymal Bone Marrow Cells to Subjects With Heart Failure of Non-ischemic Etiology,” aims to test if CardioCell’s approach is safe and provides evidence of improvement in participants with non-ischemic chronic HF.
“CardioCell is very encouraged by the initial results of this Phase IIa chronic heart failure trial,” says Dr. Sergey Sikora, CardioCell’s president and CEO. “Now that we’ve met our target enrollment number, we anticipate presenting preliminary results later this year and proceeding to a larger chronic heart failure study to assess clinical outcomes.”
Dr. Javed Butler, a noted cardiologist who co-chairs CardioCell’s Heart Failure Advisory Board and serves as CardioCell’s Scientific Advisory Board Member, has been studying this condition for more than a decade and is leading the effort in designing protocols for CardioCell’s chronic heart failure studies. “To test safety and preliminary efficacy, we designed this CardioCell chronic heart failure clinical trial to use this novel intervention in a very carefully selected group of patients who met rigorous inclusion and exclusion criteria,” says Dr. Javed Butler, Chief of Cardiology at Stony Brook University. “We are happy to report that we met the target participant enrollment and are very carefully monitoring progress.”
The Phase IIa study protocol delivers ischemia-tolerant mesenchymal stem cells (itMSCs) via intravenous infusion and investigates if the itMSCs show signs of improvement in participants with non-ischemic cardiomyopathy. More details on the study are available at: http://clinicaltrials.gov/ct2/show/NCT02123706.
Only CardioCell’s chronic HF therapies feature itMSCs, which are exclusively licensed from CardioCell’s parent company Stemedica. Unlike MSCs grown under normoxic conditions, Stemedica’s 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.
About CardioCell LLC
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.
About Stemedica Cell Technologies Inc.
Stemedica Cell Technologies Inc. is a global biopharmaceutical company that manufactures best-in-class allogeneic adult stem cells and stem cell factors. The company is a government licensed manufacturer of cGMP, clinical-grade stem cells currently used in US-based clinical trials for acute myocardial infarction, chronic heart failure, cutaneous photoaging, ischemic stroke and Alzheimer’s disease. Stemedica’s products are also used on a worldwide basis by research institutions and hospitals for pre-clinical and clinical (human) trials. Stemedica is currently developing additional clinical trials for other medical indications using adult, allogeneic stems cell under the auspices of the FDA and other international regulatory institutions. The company is headquartered in San Diego, California, and can be found online at www.stemedica.com.