Safety and Efficacy of Autologous Transplantation of iPSC-RPE in the Treatment of Macular Degeneration
NCT ID: NCT05445063
Last Updated: 2022-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
10 participants
INTERVENTIONAL
2022-08-31
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Participants receiving intervention
Participants will receive autologous transplantation of induced pluripotent stem cell-derived retinal pigment epitheliums.
Autologous iPSC-derived RPE
Autologous transplantation of iPSC-derived RPE
Interventions
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Autologous iPSC-derived RPE
Autologous transplantation of iPSC-derived RPE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
75 Years
ALL
No
Sponsors
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Beijing Tongren Hospital
OTHER
Responsible Party
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Locations
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Beijing Tongren Hospitol,Capital Medical University
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021-214
Identifier Type: -
Identifier Source: org_study_id
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