Stemedica Cell Technologies, Inc is a biotechnology company that has made stem cells for transplantation for a variety of maladies. One of their latest inventions is called ischemic tolerant mesenchymal stem cells or itMSCs. Such an invention has made Stemedica one of the leaders in adult allogeneic stem cell manufacturing, research and development. Transplantation of itMSCs has produced significant improvements in the pumping ability of the left ventricle in patients who had experienced a heart attack. Data from this study was presented at the 26th American College of Cardiology (ACC) meeting in Chicago, on March 26, 2012. The presentation by Daniyar Jumaniyazov, MD, PhD and Nikolai Tankovich, MD, PhD, President and Chief Medical Officer of Stemedica revealed this data to the meeting attendees.
45 patients who had just experienced a heart attack were given angioplasty and the placement of coronary artery stents (percutaneous infusion). Then these patients were divided into a treatment and a control group. The treatment group received intravenous infusion of itMSCs that were developed by Stemedica on the seventh day after the heart attack. The control group received normal saline with no cells. At the end of three months, those in the treatment group showed an 11-point improvement in their left ventricle ejection fractions (the amount of blood pumped with each heart contraction) in comparison with the control group. These improvements returned the ejection fraction of the treated patients to normal levels. The control group only showed a level of improvement expected with standard of care, but their ejection fractions remained below normal.
There were other markers that were improved in the treated group in comparison to the control group. Patients in the itMSC-treated group had lower levels of C-reactive protein and brain natriuretic protein (BNP), both of which are indicators of inflammation. Surveys of patients in the treated group also improved in quality of life indicators. Magnetic Resonance Imaging (MRI) performed six days and again 30 days after the heart attack showed significant decreases in lesion size in the treated group, but no such improvements were observed in the control group. Patients in this study will be followed for one year.
Nabil Dib, MD, MSc, FACC, Director, Clinical Cardiovascular Cell Therapy & Associate Professor of Medicine at the University of California, San Diego noted, “Data from this early clinical trial are very promising. If these results continue as patients are followed longer term, and if they can be replicated in a larger clinical trial, then Stemedica’s ischemic tolerant allogeneic mesenchymal stem cells may well play an important role in the treatment of heart disease.”
Jackie See, MD, FACC, an interventional cardiologist who specializes in stem cell research in Fullerton, California, commented: “These are impressive results and provide a great deal of hope for patients with heart disease. Stents open up the narrowed blood vessels. With the addition of stem cells, we can potentially rescue some of the damaged myocardial cells, promote new blood vessel growth, decrease inflammation, and strengthen the damaged muscle. I can see a day in the near future when intravenous itMSC administration becomes part of the standard of care following an acute myocardial infarct.”
Dr. Tankovich raised a key point about the research, by stating, “This study highlights the importance of using allogeneic stem cells specifically manufactured to be effective in the toxic tissue environment following a heart attack. In vitro, we know that our itMSCs secrete more of the important healing factors in response to ischemia. Our cells also retain their ‘steminess’, remaining undifferentiated and potent throughout the manufacturing process. They also pass the most stringent tests for infectious disease, acute and chronic toxicity and tumorigenicity, and they are immune privileged. These are some of the advantages of using a well characterized, homogeneous population.”
This experiment used borrowed cells from a healthy donor that were expanded in the laboratory. Dr. See noted that the importance of used borrowed cells: “Results from a large multi-center study supported by the National Heart, Lung, and Blood Institute, presented at the ACC, showed that bone marrow derived stem cells taken from older, sicker patients were not very effective in improving heart function. This is understandable, because these stem cells no longer have the power to differentiate, migrate, engraft and secrete the factors that are necessary for wound healing. So the patients who most need the treatment do not have potent stem cells to accelerate the cardiac healing process.”
Dr. Tankovich further notes that providing enough stem cells for thousands of patients who could benefit from Stemedica’s itMSC treatment is not an issue. “With our advanced expansion techniques, with only four passages, from a single tissue donation, we can treat half a million patients.”
This placebo-controlled, blinded Phase II clinical trial was conducted according to ICH guidelines at the National Medical Research Center (NMRC) in Astana, Kazakhstan. The NMRC is Kazakhstan’s premier medical research institute and internationally known for initial assessment and treatment of returning NASA astronauts. Based upon the outcome of this trial, NMRC is planning a Phase III trial using Stemedica’s itMSCs for a larger population.
Stemedica is planning a parallel Phase II clinical trial in the United States and Switzerland. The U.S. based trial will take place under Stemedica’s existing IND for the itMSCs. Swissmedic has found Stemedica’s itMSCs acceptable for clinical trials from Phase I to Phase III.