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Medical center to study stem cell therapy for stroke: national study to use company's stem cell product.


CLEVELAND, Ohio, August 7, 2012 -- A major medical center here is launching a national study looking at the safety and effectiveness of new medication developed from a company's proprietary mix of adult stem cells for the treatment of ischemic stroke.

The Phase 2 study at University Hospitals (UH) Case Medical Center, will use a cell therapy product called MultiStem developed by the Cleveland-based biotechnology company Athersys.

Ischemic stroke is caused by blockage in an artery in or to the brain, that impedes blood flow, and that can result in serious disability or even death.

MultiStem is a proprietary medication made from a patented class of early adult stem cells called Multipotent Adult Progenitor Cells or MAPCs that are obtained from the bone marrow.

Hundreds of thousands to millions of doses can be made from the bone marrow cells of one donor. The cells do not come from the patient, so can be made in advance, stored in the hospital and be used off the shelf.

Cathy Sila, M.D., principal investigator of the study and director of the Stroke and Cerebrovascular Center at UH Case Medical Center, said that the objectives of the study are to determine the highest well-tolerated and safest single dose of MultiStem in patients with ischemic stroke and to determine the efficacy of MultiStem on functional outcome in ischemic stroke patients.

"Current therapy for stroke is unfortunately very limited. There is only one drug, tPA, that is approved for use in patients with acute ischemic stroke, and tPA needs to be administered within hours of the onset of the stroke," Sila said. "Despite public education and the development of Stroke Centers, only about four percent of all ischemic stroke patients presenting to the hospital within 24 hours of their symptoms are eligible for tPA therapy. We need to develop new drugs and biologic treatments to effectively treat ischemic stroke and the damage resulting from the stroke in a wider time window so more patients can be eligible for treatment."

"Unlike conventional drugs, we believe that MultiStem therapy provides benefit in multiple ways when administered after an acute ischemic stroke," said Dr. Robert W. Mays of Athersys. "From our preclinical work, MultiStem cells appear to reduce the local inflammatory response and protect neurons in the brain, while modulating the body's general immune response and inflammation which leads to additional damage to the brain in the days immediately following the stroke. This is an entirely new concept for how cell therapies may provide benefit following CNS injury, and we are very excited by the potential of MultiStem therapy to treat stroke."

"We're trying to improve the functional outcome after a stroke," Sila said. "If MultiStem therapy ultimately proves to be effective when given at 24-36 hours after the stroke, it could mean that the majority of stroke victims would be eligible for treatment."

The national study will involve approximately 25 sites with the goal of enrolling 140 patients. It will be double-blind, randomized, and placebo-controlled.

The study is funded by Athersys.

Athersys has advanced four MultiStem programs to clinical stage, including for the treatment of acute myocardial infarction, ischemic stroke, inflammatory bowel disease, and to reduce the incidence of severe graft vs. host disease following hematopoietic stem cell transplant.

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Title Annotation:In The Clinic ...
Publication:Stem Cell Business News
Geographic Code:1U3OH
Date:Aug 13, 2012
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