More than half a million Americans each year have their first heart attack, a sudden blockage of an artery that deprives heart muscle of blood and oxygen. The resulting injury and scarring often contribute to a gradual loss of the heart's pumping strength, a condition known as congestive heart failure.
Researchers hope that cellular cardiomyoplasty, the use of transplanted stem cells to replace lost heart muscle cells, will do what current treatments cannot: prevent heart muscle loss after heart attack. Animal studies have shown that MSCs injected into heart muscle following a heart attack decreased the death of muscle cells and increased pumping strength.
The new study is a randomized, double-blind, placebo-controlled, Phase I clinical trial with patients randomized to receive either an injection of 0.5 million, 1.6 million or 5.0 million cultured adult mesenchymal stem cells (tradename: Provacel) per kilogram of body weight, or placebo. There will be 17 active study sites.
Along with the treatment or placebo, all patients will receive standard treatment, including techniques to maximize blood flow to damaged areas, pain relief, oxygen, anti-coagulants, beta-blockers, nitrates, ace-inhibitors and advice on reducing risk factors.
Forty-eight patients will participate in the trial, 22 of which have already been enrolled. Male and female patients are eligible and must be between the ages of 21 and 85 and in good overall health, with the exception of a recent heart attack. Trial entry must
Contact: Greg Williams
University of Rochester Medical Center