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.
More than 80 percent of stroke patients have ischemic strokes, where a clot causes an obstruction in an artery leading to the brain, restricting blood flow. On average, someone suffers a stroke every 40 seconds in the United States, and someone dies of a stroke every three to four minutes. Each year, about 795,000 people experience a new or recurrent stroke.
Stroke is the fourth leading cause of death and the leading cause of serious long-term disability in the United States, costing the nation an estimated $74 billion each year.
About the Methodist Neurological Institute Eddy Scurlock Stroke Center
With 18 beds, the Eddy Scurlock Stroke Center at the Methodist Neurological Institute in Houston is the largest dedicated stroke unit in the Texas Medical Center and designated a certified primary stroke center by Det Norsk Veritas. The Center is a leader in all areas of stroke research, including diagnosis, innovative treatment, prevention, rehabilitation and recovery. The Methodist NI and its stroke outreach education programs at all Methodist system hospitals are also the beneficiaries of the Taking Strides4Stroke Community Awareness Campaign, which promotes education and awareness of stroke symptoms, treatment, prevention and research.
For more information, visit the Eddy Scurlock Stroke Center or call 713-790-3333