Monday, April 19, 2010

Adult stem cell study in Michigan focusing on heart attack patients

Michigan Stem & Regenerative Medicine Program of the Michigan CardioVascular Institute and Covenant Health Care are conducting a Phase II clinical trial to evaluate the effectiveness of an adult stem cell therapy called Prochymal which intends to reduce inflammation and promote regeneration in patients who have recently had a heart attack. Two Michigan residents have already received the treatment.

Dr. Safwan Kassas, an interventional cardiologist with MCVI, has successfully infused two patients, William C. Smith, 60, of Bay City, in December, and Brenda Sigmund, 62, of Caro, in January....

Kathleen Mostek, director of research and regenerative medicine for MCVI, 1015 S. Washington in Saginaw, said the stem cells were taken from five volunteers, grown in a lab and stored in a bank in a freezer.

“This protocol is adult stem cells, they are the same for everyone in the world, with no rejection,” Mostek said.

The Prochymal investigational therapy was developed by Osiris Therapeutics Inc., of Columbia, Md., and contains mesenchymal stem cells taken from the bone marrow of healthy, screened adult volunteer donors, Mostek said.

Studies have shown this formulation to be universally compatible, similar to type O blood, the universal donor....

The double-blind, placedo-controlled stem cell study is being conducted in the U.S. and Canada and will enroll about 220 patients. To be eligible for the trial, patients must have experienced their first heart attack within seven days.

A heart attack occurs when blood flow is suddenly and completely blocked. Phase I of the trial involved 53 patients and found adverse effects were lowered, with improved heart function and irregular heartbeat reduced when comparing patients treated with Prochymal to the placebo group, Mostek said.