Researchers Launch Phase II Trial of Stem Cells and Acute Heart Attack

Science Daily, December 8, 2009

Doctors at the University of Texas Medical School at Houston have announced initiation of an efficacy-finding study in the area of heart failure using a "universal donor" stem cell product called "Prochymal". This cell therapy drug is under development by the company Osiris Therapeutics and is the subject of substantial scientific interest internationally. Prochymal has made it to Phase III trials in the area of Graft Versus Host Disease, a side effect of bone marrow transplantation, however, data was not sufficiently strong to warrant FDA approval. Prochymal is made from the bone marrow mesenchymal stem cells of healthy human volunteers. It is a unique stem cell product in that it does not require matching with the recipient.

Data from Phase I clinical trial of Prochymal have been published in the Journal of the American College of Cardiology. The researchers involved in the Phase I trial reported that patients who received Prochymal intravenously after a heart attacked did not have adverse effects associated with the stem cell infusion. Therapeutic benefits were observed in the treated but not control patients, including reduction in number of arrhythmias, improved heart and lung function, and improvement in overall condition.

"We are able to use a stem cell product that is on the shelf without prior preparation of anything from the patient, and this product appears to be able to help the heart muscle recover after a heart attack," said Ali E. Denktas, M.D., the trial's Houston site principal investigator and assistant professor of cardiology at the UT Medical School at Houston. "This means patients have the potential to recover quicker with less risk of an immediate secondary attack."

The first patient for the Phase II study at the Houston site was recruited today. The heart attack victim Melvin Dyess, 49, received an intravenous infusion of either the stem cells or placebo as part of the protocol of the double-blind study. The procedure took place at the Memorial Hermann Heart & Vascular Institute-Texas Medical Center. Denktas said UT Medical School researchers will continue to enroll willing patients into the Phase II study who are admitted to Memorial Hermann-Texas Medical Center. Neither patients nor their physicians know whether they received the stem cell drug.