Athersys, Inc. 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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