Status:
NOT_YET_RECRUITING
Preparation of Patient Autologous Induced Pluripotent Stem Cell-derived Retinal Cells for AMD
Lead Sponsor:
Zhongshan Ophthalmic Center, Sun Yat-sen University
Conditions:
Age-Related Macular Degeneration
Eligibility:
All Genders
55-80 years
Brief Summary
This project intends to collect participant somatic cells to prepare autologous induced pluripotent stem cell-derived retinal cells for future cell therapy of age-related macular degeneration patient.
Detailed Description
One or more types of somatic cells will be collected from every participant by collecting approximately 100\~500 ml of midstream urine, 20\~30 ml of peripheral blood, skin biopsies (3mm), conjunctiva ...
Eligibility Criteria
Inclusion
- Aged 55-80 years;
- Clinical diagnosis is consistent with the definition of advanced age-related macular degeneration;
- The BCVA of the target eye will be lower than 20/200;
- -8.00 D \< refraction \< +8.00 D, 21 mm \< anteroposterior axis≤ 28 mm;
- Voluntary as test subjects, informed consent, regular follow-up on time;
- Voluntary as test subjects to join the associated clinical research on autologous iPSC-derived retinal cell therapy for AMD (ethical approval and informed consent documents will be applied and signed separately);
Exclusion
- Macular atrophy caused by other diseases in addition to AMD;
- Malignant tumor and history of malignancy;
- Any immune deficiency;
- Lens opacities (affecting the central vision), glaucoma, uveitis, retinal detachment, inherited retinal dystrophy, optic neuropathy, and other ocular histories;
- Other intraocular surgery histories besides cataract surgery;
- Severe heart failure or the left ventricular ejection fraction \<35% in the previous 6 months;
- Dialysis or eGFR \<20ml/min/1.73m2;
- Urine protein/urine creatinine ratio ≥1g/g;
- Creatinine or albumin/urine creatinine ratio ≥600mg/g;
- Chronic liver disease with ALT three times over the upper limit of normal value;
- Combined with severe systemic diseases, such as heart failure, liver disease, COPD, etc.
- Combined with severe infectious diseases, such as HIV, HBV, HCV, syphilis, etc.
- HCV-RNA positive, HBV-DNA \>103 IU/ml, or TB, etc., during the infectious period;
- Use anticoagulant, or the platelet function is still not restored to normal after stopping antiplatelet drugs for 10 days;
- Abnormal blood coagulation function or other laboratory tests;
- Use glucocorticoids, immunosuppressive drugs, or antipsychotic drugs in the previous 3 months;
- Use antipsychotic drugs in the previous 3 months, such as antidepressants drugs, antimanic drugs, etc.
- Allergy to tacrolimus or other macrolides;
- A history of addiction to alcoholism or prohibited drugs;
- Be participating in other intervention clinical trials or receiving other study medications;
- Informed refusal；
- Some other situations which might increase the risks of the subjects or interfere with clinical trials, such as mental disorders, cognitive dysfunction, etc.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05991986
Start Date
August 1 2025
End Date
July 31 2026
Last Update
January 28 2025
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