ASP7316

ASP7316 is a regenerative cell therapy consisting of a monolayer of human embryonic stem cell-derived retinal pigment epithelial (hESC-RPE) cells. Developed by the Astellas Institute for Regenerative Medicine (AIRM), the therapy involves seeding RPE cells onto a synthetic basement membrane to create a "patch" that is surgically implanted into the sub-retinal space. This approach is designed to replace the damaged RPE layer and restore the functional interface between the retina and the choroid in patients with advanced macular degenerative diseases. ASP7316 is distinct from Astellas' other RPE program, ASP7317, which utilizes a cell suspension formulation. Clinical evaluation of ASP7316 has included long-term safety surveillance studies (such as NCT04004208) and follow-up assessments of patients treated in early-phase trials, demonstrating the persistence and functional potential of the transplanted monolayer over several years in conditions such as dry age-related macular degeneration (AMD) and neovascular AMD (nAMD).

Other names

hESC-RPE monolayerhESC-RPE patchhuman embryonic stem cell-derived retinal pigment epithelial monolayer