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Aastrom Biosciences Announces Initiation of Patient Enrollment in REVIVE Phase 3 Clinical Trial of Ixmyelocel-T

Aastrom Biosciences, Inc. (Nasdaq: ASTM) has begun patient enrollment in the REVIVE Phase 3 clinical trial to assess the efficacy and safety of ixmyelocel-T in the treatment of patients with critical limb ischemia. The primary endpoint of the trial will be amputation-free survival at 12 months. REVIVE is the largest randomized, double-blind, placebo-controlled, multicenter study ever conducted in patients with CLI.

The Phase 3 trial will be conducted at 80 sites in the United States and will include 594 CLI patients who have no option for revascularization and also have existing tissue loss due to ischemia. Patients will be followed for a total of 18 months, including 12 months from randomization for efficacy and an additional six months for safety.

Posted-In: News FDA

 

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