Phase III SPA OK'd for Aldagen Limb Ischemia Stem Cell TherapyPrivately held Aldagen Inc. has reached a special protocol assessment agreement with the FDA on the design, endpoints and planned statistical analysis of a Phase III trial testing the Durham, N.C.-based firm's adult stem cell therapy ALD-301 in patients with advanced limb ischemia, a condition characterized by significant impairment of blood flow to the legs and feet caused by a blockage of the arteries. The company is aiming to start the trial by the end of this year, pending a new financing round or a partnering agreement to fund the study. |