No cell therapy for macular degeneration has achieved FDA approval as of now. Several investigational products are in phase I or II clinical trials. The regulatory pathway is complex because the eye is immunologically privileged, and safety thresholds for vision-threatening side effects (inflammation, retinal detachment, proliferation) are stringent.
Macular degeneration—both age-related (AMD) and inherited forms—involves progressive death of photoreceptor cells (rods and cones) in the central retina. In AMD, a combination of lipid accumulation (drusen), oxidative stress, and chronic inflammation triggers degeneration of the retinal pigment epithelium (RPE), the supportive layer feeding photoreceptors. In inherited retinal dystrophies, genetic mutations directly compromise photoreceptor function or survival. Cell therapy approaches aim to replace lost photoreceptors or RPE cells using fetal-stage stem cells, placental MSCs, or induced pluripotent stem cell (iPSC)-derived retinal cells. These cell types can differentiate into photoreceptors or RPE in controlled environments. The proposed mechanism involves transplantation of functional cells into the macula, where they integrate into damaged retinal circuits and restore light sensitivity and signal transmission to the brain.
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