Osiris Therapeutics, Inc. has announced positive six-month results in a groundbreaking clinical trial evaluating PROVACEL™, an adult mesenchymal stem cell (MSC) therapy for the treatment of heart disease.
In a 53-patient, double-blind, placebo-controlled study evaluating the safety and preliminary efficacy of the intravenous administration of PROVACEL, heart attack patients receiving the therapy had lower rates of adverse events, such as cardiac arrhythmias, as well as significant improvements in heart, lung and overall condition.
Joshua Hare M.D., the trial’s lead investigator, presented the data this morning at the American College of Cardiology’s Innovation in Intervention: i2 Summit.
“We are extremely enthusiastic and encouraged by the degree to which these results indicate that MSCs are not only safe, but also appear to clinically improve patients who have suffered a heart attack,” said Dr. Hare, who is the Lemberg Professor of Medicine at the Miller School of Medicine, University of Miami; Chief of the Cardiology Division; and Director of the School’s Interdisciplinary Stem Cell Institute.
“The results consistently show patient improvement with regard to heart and lung function, and indicate global improvements in well-being. These findings strongly support the ongoing development of PROVACEL for acute myocardial infarction and possibly other forms of heart and lung disease,” Dr. Hare continued.
C. Randal Mills Ph.D., President and CEO of Osiris Therapeutics, said: “We were confident in the safety profile given our previous experience using the intravenous form of these stem cells to treat other diseases in later stage clinical trials. However, the magnitude of the across-the-board improvement was surprising. These data further validate the broad clinical applicability of our stem cell technology. Based on these encouraging results, we have started working on the design of the next stage of clinical trials.”