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

  • STATUS
    Recruiting
  • participants needed
    9
  • sponsor
    Shanghai East Hospital
Updated on 8 November 2020
retinal pigment

Summary

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.

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.

Details
Condition age-related macular degeneration
Treatment HuRPE
Clinical Study IdentifierNCT03215576
SponsorShanghai East Hospital
Last Modified on8 November 2020

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