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

General Information

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.
Description The investigators will generate iPSC lines from recruited participants and differentiate the iPSC into RPE. Autologous iPSC-derived RPE will be transplanted into participants eyes by subretinal injections. The safety and efficacy will be closely monitored and analyzed.
Clinical trials phase Phase 1
Start date (estimated) 2022-08-01
End date (estimated) 2026-12-31
Clinical feature
Label age related macular degeneration
Description A degeneration of macula and posterior pole that is characterized by a loss of vision in the center of the visual field (the macula) resulting from damage to the retina and resulting in blurring of the sharp central vision.; OMIM mapping confirmed by DO. [SN].

Administrative Information

NCT number NCT05445063
ICTRP weblink
Other study identifiers
Name 2021-214
Source weblink
Public contact
Public email
First name Xiaohui
Last name Zhang
Phone +0086-(010)58265915
Address freetext
Sponsors Beijing Tongren Hospital


Which differentiated cell type is used
Label retinal pigment epithelial cell
Description An epithelial cell of the retinal pigmented epithelium.


Recruitment Status Recruiting
Estimated number of participants 10