red by the SPECT total severity score, (-256 versus +13, p=0.01). Further, patients receiving 10 or more million cells showed a trend towards improvement in ejection fraction, the percentage of blood pumped out of a ventricle with each heartbeat, (+4% versus +1%); end systolic volume (-5.7mL versus -0.1mL); and infarct size, tissue death due to loss of adequate blood supply, (-10% versus -3%) at six month follow-up. No study-related significant adverse events were reported.
"We are very encouraged that our latest findings continue to show the potential for a patient's own stem cells to reduce serious long-term complications from a heart attack," said Arshed Quyyumi, M.D., FRCP, FACC, Professor of Medicine, Cardiology, at Emory University School of Medicine and the trial's principal investigator. "This study has potentially set an important dosing threshold that offers greater protection against future down-stream adverse events, with no impact on the safety profile. Importantly, the treatment regimen is such that there is no change to our standard treatment practices. We look forward to beginning a Phase II trial."
Of the 1 million heart attacks in the U.S. each year, nearly 20% are severe enough to cause ventricular remodeling. Amorcyte's patented technologies and cGMP (current good manufacturing practices) manufacturing processes address the therapeutic and commercial challenges to post-MI stem cell treatment. Unlike other approaches, Amorcyte's technology has established cell product identity, purity, dose and potency, along with sterility and product shelf-life.
A previously published meta-analysis(1) of prior clinical trials, which included a cumulative 698 patients who received intracoronary autologous cell therapy after AMI, showed a significant improvement in ejection fraction, end systolic volumes, infarct size, reduction in subsequent MI's, and trends towards reduced deaths, admissions Page: 1 2 3 4 Related biology technology :1
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