Safety and Efficacy of Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium in the Treatment of Macular Degeneration

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing Tongren Hospitol,Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Xiaohui Zhang
zhangxh711@126.com
+0086-(010)58265915
Time Frame
Start Date: 2022-08
Estimated Completion Date: 2026-12
Participants
Target number of participants: 10
Treatments
Experimental: Participants receiving intervention
Participants will receive autologous transplantation of induced pluripotent stem cell-derived retinal pigment epitheliums.
Sponsors
Leads: Beijing Tongren Hospital

This content was sourced from clinicaltrials.gov

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