NCT05991986尚未招募不适用
Production of Patient Autologous Induced Pluripotent Stem Cell-derived Retinal Cells for Age-related Macular Degeneration
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- somatic cell collection
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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);
排除标准
- •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.
结局指标
主要结局
somatic cell collection
时间窗: 2023.8.1~2026.7.31
somatic cell collection
次要结局
未报告次要终点
研究者
Xiufeng Zhong
Prof
Zhongshan Ophthalmic Center, Sun Yat-sen University
相似试验
Enrolling By Invitation
1 期
Autologous iPSC-Derived Dopamine Neuron Transplantation for Parkinson's DiseaseParkinson DiseaseNCT06422208Penelope J. Hallett, Ph.D.12
招募中
1 期
Safety and Efficacy of Autologous Transplantation of iPSC-RPE in the Treatment of Macular DegenerationMacular DegenerationNCT05445063Beijing Tongren Hospital10
招募中
1 期
Treating Parkinson's Disease Through Transplantation of Autologous Stem Cell-Derived Dopaminergic NeuronsParkinson DiseaseNCT06687837Jeffrey S. Schweitzer, MD, PhD8
终止
不适用
Generation of an Induced Pluripotent Stem (iPS) Cell Bank Immune Matched to a Majority of the US PopulationiPS Cell Manufacture and BankingNCT03434808Center for International Blood and Marrow Transplant Research19
招募中
1 期
Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart DiseaseUniventricular HeartHeart Failure NYHA Class IIIHeart Failure NYHA Class IVCongenital Heart DiseaseNCT05647213HeartWorks, Inc.50