Advanced Cell Technology Receives FDA Clearance to Initiate Clinical Trials
Advanced Cell Technology, Inc. (Santa Monica, CA) announced that it received clearance from the US Food and Drug Administration (FDA) for the company’s Investigational New Drug application to treat dry AMD using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs), according to a company news release.
Advanced Cell Technology is now permitted to initiate a phase 1/2 multicenter clinical trial to treat patients with dry AMD, and is the first company to receive FDA clearance for two hESC trials. The phase 1/2 trial will be a prospective, open-label study that is designed to determine the safety and tolerability of the RPE cells following subretinal transplantation into patients with dry AMD. Twelve patients will be enrolled in the study at multiple clinical sites.
“Using our clinical-grade hESC lines, we are able to generate a virtually unlimited and reproducible supply of healthy RPE cells,” Robert Lanza, MD, Chief Scientific Officer, Advanced Cell Technology, said in a news release. “Because only a small number of cells (50–200 K) are needed to treat each patient, manufacturing and distribution of the therapeutic product is scalable with many similarities to the drug businesses that pharmaceutical companies understand well.”
Advanced Cell Technology said that it also plans to concurrently use RPE cells in a phase 1/2 clinical trial to treat patients with Stargardt macular dystrophy.