Macular Degeneration Clinical Trial
Official title:
Early Phase I Study of the Safety and Preliminary Efficacy of Human Fetal Retinal Pigment Epithelial(fRPE) Cells Subretinal Transplantation in Age-Related Macular Degeneration(AMD) Patients
Early Phase I Study of the Safety and Preliminary Efficacy of Human Fetal Retinal Pigment Epithelial(fRPE) Cells Subretinal Transplantation in Age-Related Macular Degeneration(AMD) Patients
This study is a perspective, single-arm and open-labeled investigation of the safety and
preliminary efficacy of unilateral subretinal transplantation of fRPE cells in subjects with
dry Age-Related Macular Degeneration and non-exudative AMD. The investigators will recruit
and enroll 6 patients based on specific inclusive/exclusive criteria. Experimental and
self-controlled eye will be determined based on best-corrected visual acuity (BCVA). The eye
with BCVA of no more than 20/400 will be determined as experimental eye, which will be
divided into 3 groups and undergo subretinal injection of 3 different dosages of fRPE cells
(100.000, 200,000 or 500,000) respectively, while the other one (BCVA of more than or equal
to 20/400) as control eye, will not receive the surgery.
fRPE cells will be obtained from the fetuses aborted in the Department of Obstetrics and
Gynecology in Jiangsu Province Hospital from 2015 to 2018. The obtained fRPE cells will meet
specific inclusive/exclusive criteria and conform to Good manufacturing practices (GMP).
fRPE will be transplanted by a board-certified vitreoretinal surgeon, which will be
administered into the subretinal space of experimental eye through a standard surgical
approach.
Immunosuppressive agents will be administered orally to all subjects after transplantation.
Dosage and time duration of immunosuppressive agents will be regulated strictly relying on
the condition of immune rejection. Subjects will be monitored with ophthalmologic and
systemic examinations frequently at regular post-transplant intervals after fRPE cell
transplantation.
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