Heart Hospital of Austin First Site in World to Test Efficacy of New Adult Stem Cell Therapy to Treat Damaged Heart Tissue in Phase II Trial

Central Texas man receives groundbreaking therapy days after heart attack

AUSTIN, Texas, March 31 /PRNewswire/ — On March 30, the Heart Hospital of Austin treated the first patient in the world enrolled in a groundbreaking Phase II study designed to test the effectiveness and safety of administering adult stem cells intravenously to repair damaged heart tissue after a heart attack.

Dr. Roger Gammon, a cardiologist with Austin Heart cardiology group treated a 58-year-old Central Texas man with the experimental adult stem cell treatment, just days after his first heart attack.

“We are excited to be the first to treat a patient in this groundbreaking study and to lead the way in this important research,” states Dr. Gammon “Austin Heart and the Heart Hospital of Austin were selected because of their proven history of excellence in cardiovascular research and strong performance in the earlier Phase I trial,” Gammon adds.

Prochymal(R) is being evaluated for its ability to treat heart damage caused by a heart attack. The active ingredient in the new treatment is adult Mesenchymal Stem Cells (MSCs). The cells in the drug are from normal, healthy adult volunteer donors and are not from a fetus, embryo or animal. MSCs have the ability to develop into other types of cells and generate new tissue, including heart muscle. Prochymal(R) is a product of Osiris Therapeutics, Inc.

“There’s a lot of enthusiasm in the cardiovascular community about the potential of stem cell therapies for treating heart disease. Earlier studies have established confidence in the safety of the therapy, but more research is needed to study its effectiveness,” states Gammon.

In this prospective, double-blind, placebo-controlled Phase II study, Heart Hospital of Austin and Austin Heart researchers will study patients to determine the effectiveness and safety of Prochymal(R) for treating heart damage resulting from a heart attack. Heart Hospital of Austin is one of approximately 40 institutions in the United States and Canada participating in the study. Patients that participate in the study must receive the treatment within seven days of a heart attack. The stem cell treatment is administered intravenously and typically takes less than an hour to complete.

Prochymal(R) is currently an investigational therapy and is not yet approved by the Food and Drug Administration.

After a Heart Attack:

In 2009 alone, more than half a million Americans will have their first attack. According to the American Heart Association, 18% percent of men and 35% of women will have another heart attack within six years of their event.

SOURCE Heart Hospital of Austin