Saginaw stem-cell therapy study breaking new ground

Use of stem cells for treatment of degenerative diseases offers great hope. Unfortunately, this hope is tempered by practical
considerations. For example, in patients with heart attacks it is known that readministration of their own stem cells into the infarct related area results in profound improvement The problem with this is that stem cells need to be extracted from the bone marrow of the heart attack patient, which is a difficult and invasive procedure, and additionally the patient’s stem cells need to be processed extensively before they can be re-infused. To compound the problem, the stem cells from patients with heart attacks usually have suboptimal function. Therefore novel ways of performing stem cell therapy are needed that would make this approach practical.

Osiris Therapeutics has developed a clinical product called Prochymal, that consists of expanded bone marrow mesenchymal stem cells. This product has been demonstrated safe by intravenous infusion and perhaps more importantly, does not require matching with the recipient. Currently Osiris has completed Phase III trials and is in discussions with the FDA regarding its commercialization path for this product.

Recently Osiris completed a Phase I trial using Prochymal for treatment of post infarct pathological cardiac remodeling. These results were positive and prompted the company to initiate a Phase II study. Part of this study is being conducted at Michigan Stem & Regenerative Medicine Program of the Michigan CardioVascular Institute and Covenant Health Care under the leadership of Dr. Safwan Kassas, an interventional cardiologist .

"Stem cells represent a promising cardiac research avenue, given their potential to preserve heart function in at-risk patients," Kassas said. "Cardiologists today are unable to reverse cardiac deterioration following a severe heart attack."

To date 2 patients, William C. Smith, 60, of Bay City, in December, and Brenda Sigmund, 62, of Caro, in January where infused with the Prochymal product.

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. He stated "This protocol is adult stem cells, they are the same for everyone in the world, with no rejection,".

The study is a double-blind, placedo-controlled stem cell investigation 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.

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