Last updated on July 2017

Clinical Study of Transplanting Human Retinal Pigment Epithelial Cells for Treatment of Macular Degeneration


Brief description of study

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.

Detailed Study Description

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.

Clinical Study Identifier: NCT03215576

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