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 |
| Link |
http://purl.obolibrary.org/obo/DOID_10871 |
| 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 |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT05445063 |
| Other study identifiers |
|
| Source weblink |
https://clinicaltrials.gov/ct2/show/NCT05445063 |
| Public contact |
| Email |
zhangxh711@126.com |
| Public email |
zhangxh711@126.com |
| First name |
Xiaohui |
| Last name |
Zhang |
| Phone |
+0086-(010)58265915 |
| Country |
|
| Address freetext |
https://hpscreg.eu/browse/provider/1143 |
|
| Sponsors |
Beijing Tongren Hospital
|
Cells |
| Which differentiated cell type is used |
| Label |
retinal pigment epithelial cell |
| Link |
http://purl.obolibrary.org/obo/CL_0002586 |
| Description |
An epithelial cell of the retinal pigmented epithelium. |
|
Recruitment |
| Recruitment Status |
Recruiting |
| Estimated number of participants |
10 |
