healthmedicinet

CardioCell LLC announces two new clinical trials using its allogeneic stem-cell therapy to treat subjects with acute myocardial infarction (AMI), a problem facing more than 1.26 million Americans annually. In the United States, CardioCell is initiating a Phase IIa AMI clinical trial to evaluate the clinical safety and efficacy of its itMSCs. In addition, the Ministry of Health in Kazakhstan is beginning a Phase III AMI clinical trial on the intravenous administration of CardioCell’s itMSCs, based on the efficacy and safety found in Phase II clinical trials.

Only CardioCell’s AMI therapies feature itMSCs, which are exclusively licensed from CardioCell’s parent company Stemedica Cell Technologies Inc. Unlike all other MSCs – which are grown under normoxic conditions – itMSCs are grown under hypoxic conditions that more closely resemble the environment in which they live in the body. These bone-marrow-derived, allogeneic, mesenchymal stem cells are unique because they are grown under chronic hypoxic conditions and are ischemia-tolerant. Compared to other MSCs, itMSCs secrete higher levels of growth factors usually associated with angiogenesis and healing. The current studies have been designed to help determine if CardioCell’s itMSC-based therapies stimulate a regenerative response in AMI patients.

“CardioCell’s new Phase IIa AMI study is built on the excellent safety data reported in previous Phase I clinical trials using our unique, hypoxically grown stem cells,” says Dr. Sergey Sikora, Ph.D., CardioCell’s president and CEO. “We are also pleased to report that the Ministry of Health in Kazakhstan is proceeding with a Phase III CardioCell-therapy study following its Phase II study that was highly promising in terms of efficacy and safety. Our studies target AMI patients who have depressed left ventricular ejection fraction (LVEF), which makes them prone to developing extensive scarring and therefore to the development of chronic heart failure. CardioCell hopes our itMSC therapies will inhibit the development of extensive scarring and, thus, the occurrence of chronic heart failure in these patients.”

Taking place at Emory University, Sanford Health and Mercy Gilbert Medical Center, CardioCell’s Phase IIa AMI trial is a double-blinded, multicenter, randomized study to assess the safety, tolerability and preliminary clinical efficacy of a single, intravenous dose of allogeneic mesenchymal bone-marrow cells to subjects with ST segment-elevation myocardial infarction (STEMI).

“While stem-cell therapy for cardiovascular disease is nothing new, CardioCell is bringing to the field a new, unique type of stem-cell technology that has the possibility of being more effective than other AMI treatments,” says MedStar Heart Institute’s Director of Translational and Vascular Biology Research and CardioCell’s Scientific Advisory Board Chair Dr. Stephen Epstein. “Evidence exists demonstrating that MSCs grown under hypoxic conditions express higher levels of molecules associated with angiogenesis and healing processes. There is also evidence indicating they migrate with greater avidity to various cytokines and growth factors and, most importantly, home more robustly to ischemic tissue. Studies like those underway using CardioCell’s technology are designed to determine if we can evoke a more potent healing response that will reduce the extent of myocardial cell death occurring during AMI and thereby decrease the amount of scar tissue resulting from the infarct. A therapy that could achieve this would have a major beneficial impact in reducing the occurrence of chronic heart failure.”