European Society of Cardiology (ESC) Congress Poster Session Reveals Results From Pre-Clinical Study Using CardioCell's Stem Cells for Chronic Ischemic Cardiomyopathy

ROME, Aug. 28, 2016 /PRNewswire/ -- EUROPEAN SOCIETY OF CARDIOLOGY CONGRESS 2016 -- Study sponsor CardioCell LLC, a global biotechnology company that uses allogeneic stem cells for cardiovascular indications, announces data from its pre-clinical study "Mesenchymal stem cells grown under chronic hypoxia improve LV function and inhibit adverse remodeling in mice with chronic ischemic cardiomyopathy" at a European Society of Cardiology (ESC) Congress Poster Session. Co-Author Dr. Michael Lipinski, ‎Interventional Cardiologist at MedStar Washington Hospital Center, presents the study that was designed in collaboration with Drs. Dror Luger, Research Scientist at Washington Hospital Center and Stephen Epstein, Director, Translational and Vascular Biology Research at MedStar Heart and Vascular Institute, Chair of CardioCell's Scientific Advisory Board and Member of CardioCell's Heart Failure Advisory Board.

Pre-clinical results using a murine model prove the validity of the hypothesis that intravenous (IV) injection of CardioCell's ischemia-tolerant mesenchymal stem cells (itMSCs) exert beneficial effects on cardiac function in ischemic cardiomyopathy. The results suggest that excessive inflammation is an important cause of the progressive cardiac dysfunction seen in the control group and that itMSCs exert beneficial cardiac effects — at least, in part — by their systemic anti-inflammatory effects.

"I believe this study could have transformational effects on the treatment of heart failure (HF)," says Dr. Stephen Epstein, Director, Translational and Vascular Biology Research at MedStar Heart and Vascular Institute. "HF patients will almost certainly not be cured by a single injection of stem cells. This demonstration that IV administration of itMSCs grown under chronic hypoxia improves cardiac dysfunction in HF suggests that IV itMSC administration will be an effective and safe strategy for providing the repeated treatments that will probably be necessary in patients with ischemic cardiomyopathy."

Here is a summary of the methodology and results:

• Methodology: CD1 male mice underwent acute myocardial infarction with 45 minutes of left anterior descending artery ischemia. Echocardiography was performed 4 weeks later (considered the "baseline" study) and animals were randomized into 2 groups based on left ventricular ejection fraction (LVEF) to ensure even distribution of LVEF between the groups. Mice then received either control saline tail-vein injection (n=16) or injection of 2x10⁶ human itMSCs grown chronically at 5% O2 (n=16). Echocardiography was repeated 1 week and 3 weeks following injection. Data are presented as Mean ± SEM.
• Results: At baseline, there were no differences between the groups in regards to any echocardiographic parameters. However, mice that received a single itMSC IV injection demonstrated a significant improvement in LVEF at 1 week and had progressive improvement in LVEF at 3 weeks. The itMSC group demonstrated no change in LV end diastolic volume at 3 weeks; in marked contrast, the control group demonstrated an increase in LV end diastolic volume. Importantly, mice that received itMSC injection demonstrated a significant reduction in LV end systolic volume and a significant increase in LVEF. These improvements in LV function were associated with immunomodulatory effects: Flow cytometry demonstrated that IV itMSC treatment significantly reduced both splenic neutrophils (5.6±1.9% vs. 9.9±2.5% for control, p<0.0001) and immature myeloid cells (2.6±0.7 vs. 4.9±1.3 for control, p<0.0001). The increase in lymphocyte populations correlated with improvements in LV dimensions and function.
• Authors: Michael J. Lipinski, Dror Luger, Peter C. Westman, Sergey Sikora, Ron Waksman and Stephen E. Epstein.

The hypothesis of this study was designed to determine whether systemic effects of IV itMSC delivery improves myocardial function. It was previously thought that large numbers of stem cells must be delivered to the myocardium to exert beneficial effects on the heart. The study results show that IV itMSC injection significantly improves LV function and adverse LV remodeling in mice with chronic ischemic cardiomyopathy. The beneficial effects on LV function were associated with itMSC-induced anti-inflammatory effects.

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.

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SOURCE CardioCell LLC

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