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

Aastrom Biosciences, Inc. ASTM today announced that it has reached agreement with the U.S. Food and Drug Administration on the Special Protocol Assessment 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 who have no other treatment options.