Wednesday, April 25, 2018
CardioCell, in Collaboration With MedStar, Plans Clinical Trial That May Transform Therapy for Terminal Heart Failure Patients
Based on Promising Safety and Efficacy Data From Phase IIa Study Results for Nonischemic Cardiomyopathy and Pre-clinical Data, CardioCell and MedStar Heart &Vascular Institute Are in the Final Stages of Preparation for a Phase IIa Trial Using Its Proprietary Stem Cells on Patients With Left Ventricular Assist Device (LVAD)
SAN DIEGO — April 25, 2018 — CardioCell LLC, a Stemedica Cell Technologies Inc. subsidiary that uses allogeneic stem cells for cardiovascular indications, in collaboration with MedStar Heart & Vascular Institute (MHVI), is finalizing a protocol for a Phase IIa trial on patients with left ventricular assist devices (LVADs).
According to MHVI’s April 18 press release:
- Clinical trial planning is underway at MedStar Heart & Vascular Institute to determine whether a novel stem cell therapy will improve heart function for patients with heart failure. MedStar Heart, in partnership with CardioCell, a subsidiary of Stemedica Cell Technologies, pioneered the use of stem cells in regenerative medicine. The trial will use CardioCell’s proprietary mesenchymal stem cells (MSCs), manufactured by Stemedica. The goal is to improve outcomes in patients with heart failure and left ventricular assist devices (LVAD).
- There are nearly six million Americans with heart failure, and about 650,000 new cases occur each year. Each year 200,000 to 250,000 heart failure patients need heart transplantation, but with the very low supply of donor hearts, LVADs are being used with increasing frequency. An LVAD is a small pump that helps circulate the patient’s blood when their heart becomes too weak to pump effectively on its own. Although highly effective in alleviating symptoms and improving longevity, patients with LVAD support still have a high incidence of serious complications, including a high mortality rate. Persistent inflammation is also a probable major cause of deterioration of LVAD patients.
“CardioCell is honored to collaborate with MedStar, a prestigious premier medical research institution,” says CardioCell’s Founder and CEO Dr. Sergey Sikora. “We are excited to conduct this study and potentially help patients with an advanced stage of heart failure and have LVAD.”
Conducted in Dr. Stephen Epstein’s laboratory at MHVI, pre-clinical, mouse model studies of heart failure and acute myocardial infarction demonstrated that intravenous administration of MSCs led to “a magnitude of improved heart function that is unprecedented,” according to the MHVI press release. Results of the pre-clinical studies were described in the article “Intravenously Delivered Mesenchymal Stem Cells: Systemic Anti-Inflammatory Effects Improve Left Ventricular Dysfunction in Acute Myocardial Infarction and Ischemic Cardiomyopathy” published in Circulation Research in May 2017. Dr. Javed Butler, Chief of the Cardiology Division and Co-Director of the Heart Institute at Stony Brook University presented these study results at the prestigious European Society of Cardiology Congress in August 2016. It demonstrated safety and promising signs of efficacy in patients with stable chronic heart failure. The data was described in the article “Intravenous Allogeneic Mesenchymal Stem Cells for Nonischemic Cardiomyopathy: Safety and Efficacy Results of a Phase II-A Randomized Trial” and published in Circulation Research in January 2017.
“We look forward to joining forces with MHVI in this critical LVAD application of our stem cell technology,” says Dr. Nikolai Tankovich, Chief Medical Officer of CardioCell and Stemedica.
Only CardioCell’s chronic HF therapies feature itMSCs, which are exclusively licensed from CardioCell’s parent company Stemedica. Unlike MSCs from other sources that are 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, healing, and powerful anti-inflammatory effects. The latter has been demonstrated in the pre-clinical and clinical studies cited in Circulation Research.
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. The Company has FDA Investigational New Drug Approvals for acute myocardial infarction, chronic heart failure, cutaneous photoaging, ischemic stroke, traumatic brain injury 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 agencies. The company is headquartered in San Diego, California, and can be found online at www.stemedica.com.