Preparation of Patient Autologous Induced Pluripotent Stem Cell-derived Retinal Cells for AMD

Official title

Production of Patient Autologous Induced Pluripotent Stem Cell-derived Retinal Cells for Age-related Macular Degeneration

Overview

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 biopsies (5mm×5mm), etc. Then, these somatic cells will be used to prepare patient autologous induced pluripotent stem cell-derived retinal cells for the cell therapy of age-related macular degeneration patient.

Interventions

• Other somatic cell collection
  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 biopsies (5mm×5mm), etc.

Primary outcome measures

• somatic cell collection [Time frame: 2023.8.1~2026.7.31]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05991986 · 2023KYPJ224

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗