Athersys Announces Authorization of Stem Cell Clinical Trial for Stroke in the UK
Athersys, Inc. (Nasdaq: ATHX) announced today that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved Athersys' application to expand its ongoing Phase 2 study evaluating the administration of MultiStem^® therapy to patients who have suffered an ischemic stroke. Enrollment at United Kingdom sites is expected to commence following final Ethics Committee review and the completion of final preparations at participating clinical centers.
The Phase 2 study is a double blind, placebo-controlled trial evaluating the safety and efficacy of MultiStem cells when administered to patients who have suffered a moderate to moderately severe stroke, as defined by a National Institutes of Health Stroke Scale (NIHSS) score of 8 to 20. Patients enrolled in the study receive a single intravenous dose of MultiStem therapy or placebo in the 24 to 36 hours following the stroke, which is a significant extension of the current treatment window over existing standard of care. The study is expected to enroll approximately 136 patients in total and is currently being conducted at multiple centers throughout the United States.
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