CardioCell Plans Phase IIb Clinical Trial Using Its Stem Cells for Patients With Chronic Heart Failure

SAN DIEGO, Dec. 1, 2015 /PRNewswire/ -- CardioCell LLC, a Stemedica Cell Technologies Inc. subsidiary that uses allogeneic stem cells for cardiovascular indications, intends to proceed with finalizing a Phase IIb clinical trial protocol based on recommendations from a Heart Failure Advisory Board comprising cardiology key opinion leaders and its Scientific Advisory Board members. In a recent meeting members of both boards analyzed preliminary Phase IIa safety and efficacy data from CardioCell's on-going chronic heart failure (HF) study, "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" (NCT02123706). Data from three months following a single infusion show signs of potential efficacy in the treated group in contrast to the control group. As a result, the group unanimously recommended that CardioCell expand the study into Phase IIb and designed new protocols to more definitely assess the effects of this novel intervention on cardiac function and the outcomes in patients with heart failure.

"Given the negative results of many trials conducted in patients with heart failure, innovation is required in this field. As a result of encouraging animal and clinical data, we are developing a robust Phase IIb program using CardioCell's therapy," says Heart Failure Advisory Board Co-chair Dr. Mihai Gheorghiade, Professor of Medicine and Surgery and Director of Experimental Therapeutics at the Center for Cardiovascular Innovation at Northwestern University Feinberg School of Medicine.

The proposed Phase IIb study will include approximately 600 patients with heart failure and reduced ejection fraction due to coronary artery disease and/or primary cardiomyopathy. Once the protocol is finalized and the FDA's IND approval is received, the Phase IIa study centers – Northwestern University, Emory University, the University of Pennsylvania and Stony Brook University – will be asked to participate. In addition to those sites, CardioCell is in a process of identifying more sites in the United States to conduct this relatively large Phase IIb program.

In order to assure patient safety and create the most effective Phase IIb protocol design, CardioCell assembled the following top experts for its Heart Failure Advisory Board:

• Dr. Javed Butler, the Chief of the Cardiology Division at Stony Brook Heart Institute, Co-chair of CardioCell's Heart Failure Advisory Board and CardioCell Scientific Advisory Board Member
• Dr. Mihai Gheorghiade, Professor of Medicine and Surgery and Director of Experimental Therapeutics at the Center for Cardiovascular Innovation at Northwestern University Feinberg School of Medicine, Co-chair of CardioCell's Heart Failure Advisory Board Co-chair and CardioCell Scientific Advisory Board Member
• Dr. Stephen Epstein, Director, Translational and Vascular Biology Research at MedStar Heart Institute, Clinical Professor of Medicine at Georgetown University and CardioCell Scientific Advisory Board Chair
• Dr. Gregg Fonarow, Eliot Corday Professor of Cardiovascular Medicine and Science at the University of California Los Angeles (UCLA) and Director of Cardiomyopathy Center at UCLA School of Medicine
• Dr. Barry Greenberg, Director of Advanced Heart Failure Treatment Program at the University of California San Diego (UCSD) Medical Center and UCSD Professor of Medicine
• Dr. Marco Metra, Professor of Medicine and the University of Brescia, Italy, and Editor of "European Journal of Heart Failure"
• Dr. Scott Solomon, Professor of Medicine at Harvard Medical School, Director of Non-invasive Cardiology and Director of Cardiac Imaging and Clinical Trials Endpoints Center at Brigham and Women's Hospital and Associate Editor of "Circulation"
• Dr. James Udelson, Professor of Medicine at Tufts Medical Center, Chief of Division of Cardiology at Tufts University and Editor of "Circulation: Heart Failure"

Only CardioCell's chronic HF therapies feature itMSCs, which are exclusively licensed from CardioCell's parent company Stemedica. Unlike all other MSCs – which are grown under normoxic conditions – Stemedica's bone-marrow-derived, adult, allogeneic itMSCs are unique because they are grown under hypoxic conditions. In vitro experiments demonstrate cells that are exposed to hypoxic conditions show greater homing and engraftment than cells grown under normoxic conditions. Compared to other MSCs, 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, which provides critical benefits in terms of safety, efficacy and scalability. The company has an exclusive, worldwide license from Stemedica to explore therapeutic indications for unmet cardiovascular needs, such as acute myocardial infarction (AMI), chronic heart failure (CHF) and peripheral artery disease (PAD). For more information, visit www.stemcardiocell.com.

About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies, Inc. is a global biopharmaceutical company that manufactures multiple lines of allogeneic adult stem cells and stem cell factors. The company is licensed by the State of California's Department of Public Health, Food and Drug Branch to manufacture cGMP, clinical-grade stem cells currently used in U.S.-based clinical trials for 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.

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SOURCE CardioCell LLC

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