Stem cell developer Athersys (NASDAQ:ATHX) has taken the next of many steps toward commercializing its MultiStem therapy for stroke, the most promising application for the therapy.
The Cleveland-based company detailed its plans for a phase 2 ischemic stroke clinical trial that’s estimated to involve about 140 patients, according to ClinicalTrials.gov, a website maintained by the National Institutes of Health.
The double-blind, randomized, placebo-controlled study is designed to evaluate the safety and effectiveness of treating stroke patients with MultiStem, an off-the-shelf stem cell treatment derived from the bone marrow of adults or other nonembryonic sources.
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The trial is scheduled to start enrollment this month, with October 2013 estimated as the time frame for final data collection. The trial is expected to be completed by November 2014.
A company official declined comment.
The company believes MultiStem could represent a significant advancement in treating ischemic stroke patients. The technology has shown promise in reducing inflammation, protecting damaged tissue and forming new blood vessels.
Ischemic stroke is caused by a blood clot in the brain and accounts for 87 percent of all stroke cases.
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As for the reason that stroke is the most promising application of MultiStem — which is also being investigated for the treatment of heart attack, inflammatory bowel disease, orthopedics and blood diseases — it’s simple: stroke represents the largest market.
CEO Gil Van Bokkelen has pegged the potential stroke market at $15 billion.
Still, the company faces a long, bumpy road to commercialization, with any application of MultiStem unlikely to hit the market for at least four or five years.