In news released today, CardioCell, LLC, announced that a fifth treatment center has been chosen for participation in its Phase II clinical trial that will investigate the use of allogeneic mesenchymal bone marrow cells (aMBMC) in the treatment of non-ischemic heart failure (Study #NCT02467387). Now recruiting patients for this fifth location, the clinical study launched June 2014 and has an estimated end date of April 2017.
To learn more about the announcement, see the full press release below, printed with permission from Marcie Frank, Stemedica’s Vice President, Investor Relations.
Fifth Treatment Center for CardioCell’s Chronic Heart Failure Clinical Trial Using Ischemia-Tolerant Mesenchymal Stem Cells (itMSCs) Accepts Participants
WASHINGTON, D.C — March 22, 2016 — CardioCell LLC, a Stemedica Cell Technologies Inc. subsidiary that uses allogeneic stem cells for cardiovascular indications, welcomes MedStar Washington Hospital Center as the newest site for its Phase IIa chronic heart failure (HF) clinical trial. Participant recruitment is underway at this and four other research centers, including 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.
“CardioCell is expanding its heart failure study sites in anticipation of the Phase IIb study recently recommended by our Heart Failure Advisory Board,” says Dr. Sergey Sikora, CardioCell’s president and CEO. “MedStar Washington Hospital is the perfect new location for us based on its stellar reputation for cardiology research, and we are pleased to bring this new study site online this month.”
CardioCell’s participant enrollment for the current Phase IIa chronic HF study is nearly complete. Those in the Washington, D.C., area who wish to be considered for the study can contact Praveena Machineni, clinical research coordinator at MedStar Health Research Institute, by phone at 202-877-9328 or email at [email protected].
“MedStar Washington Hospital is at the forefront of heart failure research, and we are pleased to begin recruiting for CardioCell’s Phase IIa study,” says Dr. David Majure, M.D., MPH, MedStar Heart and Vascular Institute cardiologist and principal investigator for CardioCell’s Washington, D.C., study site. “We are committed to finding new ways to improve patient outcomes, and we think this CardioCell study is an important step in that journey.”
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 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 (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 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.
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