News

Tuesday, June 14, 2016

European Society of Cardiology (ESC) Selects CardioCell’s Heart Failure (HF) Study Results for ESC Congress 2016 Late-Breaking Science Session

SAN DIEGO — June 14, 2016 — CardioCell LLC, a global biotechnology company that uses allogeneic stem cells for cardiovascular indications, announces that the European Society of Cardiology (ESC) has accepted data from CardioCell’s Phase IIa heart failure (HF) study for an ESC Congress 2016 “Hot Line” Late-Breaking Science Session, a track that features innovative approaches for novel clinical trials that are being presented for the first time. 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. Javed Butler presents the study “Safety and Efficacy of Intravenous Infusion of Ischemia-Tolerant Allogeneic Mesenchymal Stem Cells in Patients with Non-ischemic Cardiomyopathy,” whose protocol he developed in collaboration with 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 and CardioCell Scientific Advisory Board Member.

“CardioCell is honored to have data from our Phase IIa heart failure study chosen as a Late-Breaking ‘Hot Line’ Session at ESC Congress this year,” says Dr. Sergey Sikora, CardioCell’s president and CEO. “We are excited to unveil our preliminary results at such a prestigious venue that the organization claims is ‘the world’s largest and most influential cardiovascular event.’”

On Aug. 28 at 12:12 p.m. in the ESC Congress main auditorium at the Fiera di Roma, Dr. Butler presents research from the paper “Safety and Efficacy of Intravenous Infusion of Ischemia-Tolerant Allogeneic Mesenchymal Stem Cells in Patients With Non-ischemic Cardiomyopathy: Results Of Phase IIa Randomized Controlled Trial,” which was co-authored by him, Dr. Gheorghiade and the following key opinion leaders:

  • Dr. Allen Anderson, Medical Director of the Center for Heart Failure at Northwestern University’s Bluhm Cardiovascular Institute, and Principal Investigator for CardioCell’s Phase IIa HF Chicago study site
  • Dr. Robert Cole, Cardiologist and Assistant Professor of Medicine at Emory University and Principal Investigator for CardioCell’s Phase IIa HF Atlanta study site
  • 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. Raymond Kim, Professor of Medicine and Radiology at Duke University Medical Center, Founder and Co-director of the Duke Cardiovascular Magnetic Resonance Center, which analyzed the MRI images from CardioCell’s Phase IIa HF study sites
  • Dr. Ken Margulies, Professor of Medicine at the Hospital of the University of Pennsylvania and Principal Investigator for CardioCell’s Phase IIa HF Philadelphia study site
  • Dr. Arshed Quyyumi, Co-director for Emory Clinical Cardiovascular Research Institute (ECCRI), Professor of Cardiology at Emory University and CardioCell Scientific Advisory Board Member
  • Dr. Hal Skopicki, Stony Brook University’s Heart Failure and Cardiomyopathy Program Director and Ventricular Assist Device Co-Director and Principal Investigator for CardioCell’s Phase IIa HF New York study site
  • Dr. Jane Wilcox, Cardiologist at the Bluhm Cardiovascular Institute at Northwestern University Feinberg School of Medicine and Principal Investigator for CardioCell’s Phase IIa HF Chicago study site

The Phase IIa study – conducted at Emory University, MedStar Washington Hospital Center, Northwestern University, Stony Brook University and the University of Pennsylvania – delivered ischemia-tolerant mesenchymal stem cells (itMSCs) via intravenous infusion and investigated if the itMSCs showed signs of improvement in participants with non-ischemic cardiomyopathy. More details on the study are available at: http://clinicaltrials.gov/ct2/show/NCT02123706. Preliminary results are being disclosed for the first time during the “Hot Line” sessions at ESC Congress.

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, Alzheimer’s disease and traumatic brain injury. 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.