Aastrom Biosciences Inc. (ASTM), FDA Reach Protocol Agreement for Phase 3 Clinical Trial of Multicellular Therapy
Aastrom Biosciences Inc., leading developer of patient-specific, expanded multicellular therapies for the treatment of severe, chronic cardiovascular diseases, has reached an agreement with the U.S. Food and Drug Administration (FDA) regarding the Special Protocol Assessment (SPA) for the design of the company’s phase 3 REVIVE-CLI clinical trial of ixmyelocel-T. Ixmyelocel-T is the company's expanded multicellular therapy, designed to treat patients with critical limb ischemia (CLI) who have no other treatment options. CLI leads to more than 160,000 limb amputations each year in the United States, making it the most severe form of peripheral artery disease. CLI is also fatal; approximately…