Safety and Efficacy of Autologous Transplantation of iPSC-RPE in the Treatment of Macular Degeneration

Prior treatment

• 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;
• Use glucocorticoids, immunosuppressive drugs, or antipsychotic drugs in the previous 3 months;
• Be participating in other intervention clinical trials or receiving other study medications;

Other illness

• 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;
• Combined with severe infectious diseases, such as HIV, HBV, HCV, syphilis, tuberculosis, etc;
• Malignant tumor and history of malignancy;
• Allergy to tacrolimus or other macrolides;
• A history of addiction to alcoholism or prohibited drugs;
• Some other situations which might increase the risks of the subjects or interfere with clinical trials, such as mental disorders, cognitive dysfunction, etc.

Lab values

• Abnormal blood coagulation function or other laboratory tests;
• Use anticoagulant, or the platelet function is still not restored to normal after stopping antiplatelet drugs for 10 days;

Other

• One-eyed subjects;
• Lens opacities (affecting the central vision), glaucoma, uveitis, retinal detachment, optic neuropathy, and other ocular histories;
• 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;
• Any immune deficiency;
• Any immune deficiency;
• Poor compliance, difficulty to complete the study, or refusal to informed consent;

• Aged 50-75 years;
• 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.