- Athersys (NASDAQ:ATHX) announces that it has received agreement from the FDA under a Special Protocol Assessment (SPA) for the design and planned analysis of a Phase 3 clinical trial of Athersys’ novel MultiStem cell therapy product for the treatment of ischemic stroke. The results from the Phase 3 trial entitled, “MultiStem Administration for Stroke Treatment and Enhanced Recovery Study-2” (MASTERS-2), together with other available clinical data, would provide the foundation of the regulatory package to be submitted for marketing approval.
- MASTERS-2 will be a randomized, double-blind, placebo-controlled clinical trial designed to enroll 300 patients in North America and Europe. Participants will receive either a single intravenous dose of MultiStem cell therapy or placebo, in addition to standard of care. The primary endpoint will assess disability, as determined by modified Rankin Scale scores at Month 3, comparing the distribution or shift between the test and control groups. Secondary endpoints will include additional disability measurements.
- Ischemic stroke, the most common form of stroke, is caused by a blockage of blood flow in the brain that cuts off the supply of oxygen and nutrients and can result in long-term or permanent disability due to neurological damage.
- MultiStem cell therapy is a patented regenerative medicine product that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of therapeutic factors produced in response to signals of inflammation and tissue damage.