Tests patient-derived retinal cells transplanted to treat macular degeneration
Tests transplanted retinal cells made from the patient's own cells in macular degeneration.
Plain-language title generated from the registry record
Registry title: Safety and Efficacy of Autologous Transplantation of iPSC-RPE in the Treatment of Macular Degeneration
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 50 and 75 years old?
Source: NCT05445063, who can take part
Where in China
- Beijing Tongren Hospitol,Capital Medical UniversityBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Beijing Tongren Hospital
- Trial code
- NCT05445063
- Record updated
- 6 July 2022
- Original description
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.Read full original descriptionShow less
Safety and Efficacy of Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium in the Treatment of Macular Degeneration
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.
Inclusion: 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: Other intraocular surgery histories besides cataract surgery; Combined with severe systemic diseases, such as heart failure, liver disease, renal insufficiency, cor pulmonale, COPD in the previous 12 months; Use glucocorticoids, immunosuppressive drugs, or antipsychotic drugs in the previous 3 months; Be participating in other intervention clinical trials or receiving other study medications; 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; Combined with severe infectious diseases, such as HIV, HBV, HCV, syphilis, tuberculosis, etc; Malignant tumor and history of malignancy; Allergy to tacrolimus or other macrolides; A history of addiction to alcoholism or prohibited drugs; Some other situations which might increase the risks of the subjects or interfere with clinical trials, such as mental disorders, cognitive dysfunction, etc; Abnormal blood coagulation function or other laboratory tests; Use anticoagulant, or the platelet function is still not restored to normal after stopping antiplatelet drugs for 10 days; One-eyed subjects; Lens opacities (affecting the central vision), glaucoma, uveitis, retinal detachment, optic neuropathy, and other ocular histories; If female and of childbearing potential, pregnant, breastfeeding, or planning to become pregnant through the study; If male, refuse to use barrier and spermicide contraception during the study; Any immune deficiency; Any immune deficiency; Poor compliance, difficulty to complete the study, or refusal to informed consent.