Oct 21, 2015
CardioCell Board Members and Clinical Trial Leads Collaborate on Peer-Reviewed Paper Published in the Journal of Cardiovascular Medicine
SAN DIEGO — Oct. 21, 2015 — CardioCell LLC, a Stemedica Cell Technologies Inc. subsidiary that uses allogeneic stem cells for cardiovascular indications, announces that collaboration between several scientific board members and principal investigators from its clinical trial sites resulted in a peer-reviewed publication now available in the Journal of Cardiovascular Medicine. Entitled “Rational and Design of a Randomized Controlled Trial of Allogeneic Mesenchymal Stem Cells in Patients With Non-ischemic Cardiomyopathy,” the paper authors include CardioCell’s Scientific Advisory Board members Drs. Stephen E. Epstein, Arshed A. Quyyumi, Mihai Gheorghiade and Javed Butler, as well as board directors Sergey Sikora, Ph.D., and Nikolai I. Tankovich, M.D., Ph.D. Additional authors include CardioCell’s chronic heart failure clinical trial (NCT02123706) principal investigators Drs. Allen S. Anderson, Robert T. Cole and Hal A. Skopicki, clinical trial coordinator Jane E. Wilcox and MRI image analyst Dr. Raymond J. Kim.
“CardioCell is honored to have so many of its scientific advisors and clinical trial principal investigators credited for this peer-reviewed article in the prestigious ‘Journal of Cardiovascular Medicine,’” says Dr. Sergey Sikora, CardioCell’s president and CEO. “The article references CardioCell’s current, ongoing Phase IIa clinical trial for patients with non-ischemic heart failure taking place at Emory University, Northwestern University, Stony Brook University and the University of Pennsylvania, and we look forward to publishing the results next year.”
Available online via subscription or for purchase, the paper aims to describe “an ongoing study investigating the safety and efficacy of ischemia-tolerant mesenchymal stem cell (MSC) therapy in patients with non-ischemic heart failure and dysfunctional viable myocardium without scarring. This study will follow principles of the previously described mechanistic translational-phase concept whereby the effect of the study agent on laboratory and imaging markers of cardiac structure and function will be tested in a small homogenous cohort with the goal to enhance the understanding of the effect of interventions on cardiac remodeling and performance.” The article further describes that this pilot study “will explore the safety and effects on cardiac structure and function of [intravenous] injection of ischemia-tolerant MSCs in a small homogenous cohort of non-ischemic heart failure patients with reduced ejection fraction and absent replacement scarring on cardiac magnetic resonance (CMR).”
Featured in this clinical trial, 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.