NSCI is pleased to announce our successful IND application to the FDA that will enable clinical testing of a novel stem cell therapy for patients with age-related macular degeneration (AMD).
In AMD, the retinal pigment epithelial cells (RPE) at the back of the eye degenerate, causing loss of vision. Patients with AMD lose the ability to read and recognize faces, which is debilitating and isolating. 1 in 5 people over age 75 develop AMD, and there is great need to develop new therapies to slow or prevent disease progress. Dr. Jeffrey Stern and team at NSCI discovered an adult stem cell present in the RPE layer that can be used to provide new RPE cells to replace those lost to disease. Dr. Stern’s team have performed careful tests in animals that indicate safety and efficacy, and have manufactured clinical grade RPE cells. Now they have been given the green light to move to clinical testing in subjects with AMD. Plans to start the clinical trial have commensed at the University of Michigan Kellogg Eye Center, with the study lead Dr. Rajesh Rao. The clinical trial is being supported by the National Eye Institute (NEI) and Luxa Biotech and the NIH Regenerative Innovation Project (RMIP).