This project intends to perform autologous transplantation of induced pluripotent stem cell-derived retinal pigment epithelium (iPSC-RPE). The clinical-grade RPE will be transplanted into subretinal space to treat refractory age-related macular degeneration. The efficacy and safety of RPE transplants to treat macular degeneration will be monitored and analyzed with results from EDTRS, BCVA, OCT, ERG, microperimetry, and fluorescein angiography, before and after the treatment.
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;
One-eyed subjects;
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;
Lens opacities (affecting the central vision), glaucoma, uveitis, retinal detachment, optic neuropathy, and other ocular histories;
Single group
Autologous iPSC-derived RPE
Biological/VaccineAutologous transplantation of iPSC-derived RPE
Safety measure
Safety will be assessed by Adverse Events (AEs) of special interest in regards to the investigational product. This will include obtaining information about Serious Adverse Events (SAEs) that are neurologic, infectious, hematologic or fatal, any AE that causes the subject to withdraw from the study, any new diagnosis of an ocular or immune-mediated disorder, cancer (irrespective of prior history), ectopic or proliferative cell growth (RPE or non-RPE) with adverse clinical consequence, unexpected, clinically significant AE possibly related to the cell transplant procedure or the investigational product (autologous iPSC-RPE), pregnancy in a female subject or the partner of a male subject and pregnancy outcome.
Best Corrected Visual Acuity (BCVA)
Change in visual acuity will be measured by Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
Optical coherence tomography (OCT) imaging
The number of patients with serious retinal detachment, retinal hemorrhage, and cystoid macular edema, and the change in target treatment areas.
Color and autofluorescence imaging
Change in target treatment areas.
Fluorescein angiography
Change in target treatment areas.
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