Mar 10, 2015
CardioCell Adds Stony Brook University to Sites Conducting a Phase IIa Clinical Trial Using Its Stem Cells for Patients With Chronic Heart Failure
STONY BROOK, NEW YORK — March 10, 2015 — CardioCell LLC, a Stemedica Cell Technologies Inc. subsidiary that designs allogeneic stem-cell therapies for cardiovascular indications, expands patient recruitment to Stony Brook University’s Heart Institute for its Phase IIa clinical trial for chronic heart failure (HF). Recruitment for 20 qualified patients is currently underway at only Emory University in Atlanta, Northwestern University in Chicago, Stony Brook University on Long Island and the University of Pennsylvania in Philadelphia. More details on 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,” is available at: http://clinicaltrials.gov/ct2/show/NCT02123706.
“The Heart Institute of Stony Brook University Medical Center is ideally suited for CardioCell’s chronic HF study,” says Dr. Sergey Sikora, CardioCell’s president and CEO. “The hospital delivers superior cardiovascular care to all of Long Island and surrounding areas, and its state-of the-art labs are staffed by experts at handling live cells like the itMSCs used in this study’s protocols.”
“For patients whose heart failure is due to blockages in their arteries, a number of therapies – including the use of cardiac stents and bypass surgery – have been available for decades,” says Dr. Hal Andrew Skopicki, Stony Brook University’s Heart Failure and Cardiomyopathy Program Director and Ventricular Assist Device Co-Director, as well as principal investigator for CardioCell’s New York study site. “For other patients whose heart failure is due to other causes, there are currently no approved therapies that specifically try to recover their failing heart function.” CardioCell’s itMSCs secrete large numbers of cytokines and growth factors, and this FDA-approved clinical trial will test if these stem cell properties can cause the patient’s own cardiomyocytes to improve their ability to contract, eventually restoring or improving heart function.
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, 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.