Advanced Cell Technology, Inc. (ACTC.OB) Makes History with FDA Clearance for Stem Cell Clinical Trial to Treat Macular Degeneration
Advanced Cell Technology today announced U.S. Food and Drug Administration (FDA) clearance for its Investigational New Drug (IND) application to commence a Phase I/II multicenter clinical trial using retinal cells derived from human embryonic stem cells to treat patients with Stargardt’s Macular Dystrophy (SMD). This newly announced decision removes the clinical hold that the FDA had placed on the trial. The first-of-its-kind human trials will be a prospective, open-label study consisting of twelve patients that will initially be conducted to determine the safety and tolerability of the RPE (retinal pigment epithelium) cells following sub-retinal transplantation to patients with advanced Stargardt’s…