Transplanting stem cells to treat macular degeneration
Safety and Efficacy of Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium in the Treatment of Macular Degeneration
This study is testing if using a patient's own stem cells to create new eye cells can help treat age-related macular degeneration in people aged 50 to 75.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 50 Years to 75 Years |
| Sex | All |
| Sponsor | Beijing Tongren Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05445063 on ClinicalTrials.gov |
What this trial studies
This project aims to treat refractory age-related macular degeneration by performing autologous transplantation of induced pluripotent stem cell-derived retinal pigment epithelium (iPSC-RPE). Participants aged 50-75 will have their own stem cells converted into RPE cells, which will then be injected into the subretinal space of their eyes. The safety and efficacy of this treatment will be monitored using various ophthalmic assessments before and after the procedure.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50-75 with late dry AMD or wet AMD who have not responded to conventional treatments.
Not a fit: Patients with other retinal diseases or significant ocular histories that could affect the outcome may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could restore vision or slow the progression of macular degeneration in affected patients.
How similar studies have performed: While this approach is innovative, similar studies using stem cell therapies for retinal diseases have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * One-eyed subjects; * 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; * Lens opacities (affecting the central vision), glaucoma, uveitis, retinal detachment, optic neuropathy, and other ocular histories; * 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; * Combined with severe infectious diseases, such as HIV, HBV, HCV, syphilis, tuberculosis, etc; * Abnormal blood coagulation function or other laboratory tests; * 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; * Malignant tumor and history of malignancy; * Any immune deficiency; * Allergy to tacrolimus or other macrolides; * Any immune deficiency; * Use glucocorticoids, immunosuppressive drugs, or antipsychotic drugs in the previous 3 months; * Use anticoagulant, or the platelet function is still not restored to normal after stopping antiplatelet drugs for 10 days; * A history of addiction to alcoholism or prohibited drugs; * Be participating in other intervention clinical trials or receiving other study medications; * Poor compliance, difficulty to complete the study, or refusal to informed consent; * Some other situations which might increase the risks of the subjects or interfere with clinical trials, such as mental disorders, cognitive dysfunction, etc.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Tongren Hospitol,Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Xiaohui Zhang
- Email: zhangxh711@126.com
- Phone: +0086-(010)58265915
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.