Abstract
Presentation Description :
Challenges in cellular therapies include delivery of cells, poor cell survival, immune rejection, and integration into a pathologic and possibly toxic tissue. We developed a subretinal implant consisting of a polarized monolayer of allogeneic human embryonic stem cell-derived retinal pigmented epithelium (RPE) cells on a biostable synthetic Bruch's membrane. We conducted an open-label phase 1/2a clinical trial to assess the safety and preliminary efficacy in subjects with geographic atrophy (GA) / dry age-related macular degeneration. After one year, a larger proportion of treated eyes experienced a >5-letter gain when compared with the untreated eye (27% vs. 7%) and a larger proportion of nonimplanted eyes demonstrated a >5-letter loss (47% vs. 33%). Postmortem histology from one subject with very advanced disease shows the presence of donor RPE cells 2 years after implantation.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.