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Stem Cell Based Therapy Trial on Injured Heart Muscle Results

The second phase of a clinical trial testing has been launched (4/22/10) by researchers at the University of Texas Medical School in Houston. Results from Phase I of the trial were published in the Journal of the American College of Cardiology. Researchers reported that patients were treated safely with intravenous adult human mesenchymal arrhythmias, improved heart and lung function, and improvement in overall condition.

Researchers have now enrolled the 1st patient for the Phase II study at the Memorial Hermann Heart & Vascular Institute-Texas Medical Center.  “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 at the UT Medical School at Houston. “This means patients have the potential to recover quicker with less risk of an immediate secondary attack.”

 

In many cell-based therapies, doctors harvest the patient’s own cells, process them and then return them to the patient. Prochymal, developed by Osiris Therapeutics, Inc., contains adult mesenchymal stem cells from healthy donors. The cells can be stored at an emergency center until needed. For purposes of the Phase II study, Prochymal must be administered within 7 days of a heart attack.

Affecting 1.1 M Americans every year, heart attacks are caused by disruptions to the heart’s blood supply. Muscle cells can die within minutes of the blood being reduced or cut off. The body has a limited capacity to regenerate new heart muscles and repair wounds to the heart. Studies with acute myocardial infarction (heart attack) show that if you give cells of some sort to the heart relatively quickly, 5 to 10 days after the heart attack, they nest themselves in the heart and the heart improves.

But, why it improves is debatable.  Adult mesenchymal stem cells appear to have anti-inflammatory, anti-fibrotic, and tissue regenerative capacities, as shown in both animal studies and human clinical trials, according to Osiris Therapeutics, Inc (HWM & DLake, Pharmacy Drugs).