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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• somatic cell collection [Срок оценки: 2023.8.1~2026.7.31]

Критерии участия

Критерии включения

• 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);

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05991986 · 2023KYPJ224

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗