Safety and Efficacy of Autologous Transplantation of iPSC-RPE in the Treatment of Macular Degeneration
Condition(s) studied
Investigational drug(s) / intervention(s)
Autologous iPSC-derived RPE: Autologous transplantation of iPSC-derived RPE
Study 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
Primary outcome measure(s)
- Safety measure — 12 months
Safety will be assessed by Adverse Events (AEs) of special interest in regards to the investigational product. This will include obtaining information about Serious Adverse Events (SAEs) that are neurologic, infectious, hematologic or fatal, any AE that causes the subject to withdraw from the study, any new diagnosis of an ocular or immune-mediated disorder, cancer (irrespective of prior history), ectopic or proliferative cell growth (RPE or non-RPE) with adverse clinical consequence, unexpected, clinically significant AE possibly related to the cell transplant procedure or the investigational product (autologous iPSC-RPE), pregnancy in a female subject or the partner of a male subject and pregnancy outcome.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Beijing Tongren Hospitol,Capital Medical University | Beijing | Beijing Municipality | Recruiting |
More Beijing Tongren Hospital trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05445063 on ClinicalTrials.gov ↗ ← All trials in China