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RPESC-RPE-4W
- Development stage
- Phase 2
- Lead developer
- Luxa Biotechnology
- Modality
- iPSCs → Pluripotent Stem Cells → Stem Cell Therapies → Cell Therapies
- Administration
- Submacular, Subretinal
01
Overview
RPESC-RPE-4W is a cell therapy product derived from adult human retinal pigment epithelial stem cells (RPESC). These cells are differentiated for four weeks to generate progenitor-stage retinal pigment epithelium (RPE) cells, which are then transplanted under the macula to replace native RPE cells lost during the progression of dry age-related macular degeneration (dry AMD). The therapy aims to restore vision by replenishing the RPE layer that supports photoreceptor function. Early clinical data from a Phase 1/2a trial indicate promising safety and efficacy, with meaningful improvements in visual acuity observed in treated patients. The product is being developed by Luxa Biotechnology and has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for dry AMD[1][3][5][6][7].
- Other names
- human RPE stem cell-derived RPERPESC-RPEadult retinal pigment epithelial stem cell therapy
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