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Recruiting Phase 1 NCT05445063

Safety and Efficacy of Autologous Transplantation of iPSC-RPE in the Treatment of Macular Degeneration

Trial Parameters

Condition Macular Degeneration
Sponsor Beijing Tongren Hospital
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 10
Sex ALL
Min Age 50 Years
Max Age 75 Years
Start Date 2022-08
Completion 2026-07
Interventions
Autologous iPSC-derived RPE

Brief Summary

This project intends to perform autologous transplantation of induced pluripotent stem cell-derived retinal pigment epithelium (iPSC-RPE). The clinical-grade RPE will be transplanted into subretinal space to treat refractory age-related macular degeneration. The efficacy and safety of RPE transplants to treat macular degeneration will be monitored and analyzed with results from EDTRS, BCVA, OCT, ERG, microperimetry, and fluorescein angiography, before and after the treatment.

Eligibility Criteria

Inclusion Criteria: * Aged 50-75 years; * Clinical diagnosis is consistent with the definition of late dry AMD in the age-related eye disease study (AREDS), with one or more \>250 um geographic atrophy in the fovea; * Clinical diagnosis is wet AMD, but no obvious efficacy after conventional treatment; * The BCVA of the target eye will be 0.05 to 0.3; * Voluntary as test subjects, informed consent, regular follow-up on time. Exclusion Criteria: * One-eyed subjects; * Macular atrophy caused by other diseases in addition to AMD; * Suffer from retinitis pigmentosa, choroidal retinitis, central serous choroiditis, diabetic retinopathy, or other retinal vascular and degenerative diseases besides AMD; * Lens opacities (affecting the central vision), glaucoma, uveitis, retinal detachment, optic neuropathy, and other ocular histories; * Other intraocular surgery histories besides cataract surgery; * Combined with severe systemic diseases, such as heart failure, liver disease, renal insufficienc

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