Transplanted ischaemic tolerant mesenchymal stem cells (itMSC) produced significant improvement in the pumping function of the left ventricle in patients who had experienced a heart attack, according to a study presented at the 26th American College of Cardiology (ACC) meeting in Chicago, USA.
The study was presented by Daniyar Jumaniyazov and Nikolai Tankovich, president and chief medical officer of Stemedica Cell Technologies, the company that developed the technology.
Forty five patients who had experienced an acute myocardial infarction underwent reperfusion by stent and after being carefully matched, were divided into a treatment and a control group. The treatment group received intravenous infusion of itMSCs on day seven; the control group received normal saline. At the end of three months, those in the treatment group experienced an 11 point improvement in the ejection fraction of the left ventricle in comparison with the control group. This level of improvement restored the treatment group’s ejection fraction to normal levels. In comparison, the control group showed a level of improvement expected with standard of care; however, the ejection fraction remained below normal. In addition, the treatment group had statistically significant improvements in two blood markers of inflammation; levels of C-reactive protein and BNP were lower in the treated group. Patients in the stem cell treatment group also had improvement in quality of life indicators. MRI performed day six and again day 30 in the treatment group showed significant decreases in lesion size. Patients in this study will be followed for one year.
Commenting on the study, Nabil Dib, director, Clinical Cardiovascular Cell Therapy and 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 ischaemic tolerant allogeneic mesenchymal stem cells may well play an important role in the treatment of heart disease.”
According to Jackie See, an interventional cardiologist specialising in stem cell research in Fullerton, USA, “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.”
The 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 US 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.