Aldagen, Inc. has received a Special Protocol Assessment (SPA) concurrence letter from the FDA for the design of a Phase 3 study of ALD-301 for Critical Limb Ischemia (CLI). An SPA is a written agreement between the company, as the trial’s sponsor, and the FDA regarding the design, endpoints, and planned statistical analysis of the Phase 3 trial to be used in support of a Biological License Application (BLA). The SPA letter received by Aldagen from the FDA states that the Phase 3 study is adequately designed to provide necessary data that, depending on outcome, could support a BLA submission. The Phase 3 trial will be a double blind, placebo-controlled study designed to assess the ability of ALD-301 to improve clinical outcomes in patients with CLI, including amputation rates, ulcer healing and pain reduction. The study will involve patients with advanced critical limb ischemia who no longer have revascularization options. The patients will be evaluated over a six month timeframe. “We are excited to have reached agreement with the FDA on a clinical path that could ultimately lead to approval of ALD-301, which may provide an important new treatment option for advanced CLI patients with very few alternatives,” said Tom Amick, Chairman and Chief Executive Officer of Aldagen. “This SPA is also the first one for a stem cell therapy in the cardiovascular area — a significant milestone for Aldagen and the regenerative medicine field.”
