Actively Recruiting
Safety and Efficacy of Autologous Transplantation of iPSC-RPE in the Treatment of Macular Degeneration
Led by Beijing Tongren Hospital · Updated on 2022-07-06
10
Participants Needed
1
Research Sites
226 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of Autologous Transplantation of iPSC-RPE in the Treatment of Macular Degeneration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 50-75 years
- Clinical diagnosis consistent with late dry AMD with one or more >250 um geographic atrophy in the fovea
- Clinical diagnosis of wet AMD with no obvious efficacy after conventional treatment
- Best corrected visual acuity (BCVA) of the target eye between 0.05 and 0.3
- Voluntary participation with informed consent and willingness for regular follow-up
You will not qualify if you...
- One-eyed subjects
- Macular atrophy caused by diseases other than AMD
- Retinitis pigmentosa, choroidal retinitis, central serous choroiditis, diabetic retinopathy, or other retinal vascular and degenerative diseases besides AMD
- Lens opacities affecting central vision, glaucoma, uveitis, retinal detachment, optic neuropathy, or other ocular histories
- Intraocular surgery history except cataract surgery
- Severe systemic diseases such as heart failure, liver disease, renal insufficiency, cor pulmonale, COPD in the past 12 months
- Severe infectious diseases including HIV, HBV, HCV, syphilis, tuberculosis
- Abnormal blood coagulation or laboratory test abnormalities
- Pregnant, breastfeeding, or planning pregnancy if female of childbearing potential
- Male participants refusing to use barrier and spermicide contraception during the study
- Malignant tumors or history of malignancy
- Immune deficiencies
- Allergy to tacrolimus or other macrolides
- Use of glucocorticoids, immunosuppressive, or antipsychotic drugs in the past 3 months
- Use of anticoagulants or incomplete recovery from antiplatelet drugs
- History of addiction to alcohol or prohibited drugs
- Participation in other intervention clinical trials or receiving other study medications
- Poor compliance, inability to complete the study, or refusal to consent
- Other conditions increasing risk or interfering with the trial such as mental disorders or cognitive dysfunction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Tongren Hospitol,Capital Medical University
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
X
Xiaohui Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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