Macular Degeneration Clinical Trial
Official title:
Clinical Study of Transplanting Human Retinal Pigment Epithelial Cells for Treatment of Macular Degeneration
This study is an open-label investigation of the safety and preliminary efficacy of the subretinal transplantation of human retinal pigment epithelial cells on Macular Degeneration.
This study is an open-label investigation of the safety and preliminary efficacy of the sub
retinal transplantation of human retinal pigment epithelial cells on Macular Degeneration.
Nine patients are recruited through specific inclusive/exclusive criteria after signed an
informed consent. Experimental and self-controlled eye will be determined based on
best-corrected visual acuity (BCVA). The eye with BCVA of 20/200 or worse will be determined
as experimental eye, which will undergo one sub retinal injection. Three dose cohorts (100
000, 300 000, and 500 000 cells) were treated for each eye disorder, while the other eye
(BCVA 20/200 or better) as control and will not receive the surgery.
HuRPE cells are conformed with Good manufacturing practices (GMP). Certified HuRPE cells will
be administered into the subretinal space of experimental eye through a standard surgical
approach. Subjects will be monitored with ophthalmologic and systemic examinations frequently
at regular post-transplant intervals after HuRPE cells transplantation.
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