Aastrom Biosciences, Inc. Announces Agreement From FDA on Special Protocol Assessment for Phase 3 Clinical Trial in No-Option Critical Limb Ischemia Patients

ANN ARBOR, Mich., July 26, 2011 (GLOBE NEWSWIRE) -- Aastrom Biosciences, Inc. (Nasdaq:ASTM), the leading developer of patient-specific, expanded multicellular therapies for the treatment of severe, chronic cardiovascular diseases, today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on the Special Protocol Assessment (SPA) for the design of the Phase 3 REVIVE-CLI clinical trial of ixmyelocel-T, the company’s expanded multicellular therapy, in patients with critical limb ischemia (CLI) who have no other treatment options.