Physicians at the Methodist Neurological Institute are studying the use of human stem cells as a possible treatment for acute ischemic stroke, a leading cause of death and disability. Each year, stroke affects more than 15 million people around the world.
Patients whose ischemic strokes occur within one to two days of being admitted to The Methodist Hospital in Houston may be eligible to enroll in the double-blind, randomized, placebo-controlled phase 2 safety and efficacy trial of MultiStem®, a novel therapy being developed by Athersys, Inc.
"The thrombolytic tPA is still the only FDA-approved treatment for the majority of stroke cases, but unfortunately, we only have a three hour window of opportunity with this drug," said Dr. David Chiu, medical director of the Eddy Scurlock Stroke Center at Methodist and the study site's principal investigator. "By offering our acute stroke patients a broader timeframe for treatment, we hope to have the chance to effectively help many more patients."
The study will examine the effects of intravenous administration of adult stem cells that can be manufactured from a donor. In contrast to traditional bone marrow transplants, which require one donor for each patient that needs treatment, MultiStem is a patented formulation of early adult stem cells, and hundreds of thousands to millions of doses can be made from the bone marrow cells of one healthy donor. The product can be made in advance, and may be stored in the hospital and used "off the shelf".
Researchers in the clinical trial will not only look at how well the investigational therapy works for stroke treatment, but they will also monitor for potential side effects and how potent the drug is compared to placebo.
Another goal of this study is to examine some of the stem cells' effects on organs such as the spleen, which is thought to contribute to ongoing inflammation that could increase brain injury after the initial stroke. Published work from preclinical studies shows that MultiStem can provide benefits even when administered several days after a stroke has occurred, and some of the cell effects appear to occur through their action on the spleen. Animal models used in this research showed a statistically significant and durable improvement in motor skills relative to animals that received a placebo.
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