Source: University of Miami Miller School of Medicine
Date: November 30, 2009
Summary:
An FDA-approved clinical trial is the first to show that treating patients with adult stem cells after a heart attack is safe and that it appears to repair damaged heart tissue. Results of the study are published in the December 8 issue of the Journal of the American College of Cardiology.
The trial, lead by Joshua M. Hare, M.D., director of the Interdisciplinary Stem Cell Institute at the University of Miami Miller School of Medicine, found that the stem cell-treated patients had lower rates of side effects, such as cardiac arrhythmias. Moreover, "they had significant improvements in heart, lung and global function," Hare explained. "Echocardiography showed improved heart function, particularly in those patients with large amounts of cardiac damage."
The Phase I trial was designed to determine the safety and efficacy of administering Prochymal, an intravenous formulation of adult mesenchymal stem cells, in patients within days of a heart attack to lessen damage to the heart muscle. Fifty-three patients who had suffered a heart attack within one to ten days, were randomized to one of three doses of stem cells, and each dose was compared with placebo. Researchers evaluated treatment-related serious adverse affects after six months and used echocardiography to assess efficacy.
