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Treatment of Age-related Macular Degeneration by Fetal Retinal Pigment Epithelial Cells Transplantation

2016-08-17 10:53:22 | BioPortfolio

Summary

Phase I/II Study of the Safety and Preliminary Efficacy of Human Fetal Retinal Pigment Epithelial(fRPE) Cells Subretinal Transplantation in Age-Related Macular Degeneration(AMD) Patients

Description

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 (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 less than 20/400 will be determined as experimental eye, which will undergo subretinal injection of 100,000 fRPE cells, 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Age Related Macular Degeneration

Intervention

fRPE cells

Location

The First Affiliated Hospital with Nanjing Medical University
Nanjing
Jiangsu
China
210029

Status

Recruiting

Source

The First Affiliated Hospital with Nanjing Medical University

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-08-17T10:53:22-0400

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A form of MACULAR DEGENERATION also known as dry macular degeneration marked by occurrence of a well-defined progressive lesion or atrophy in the central part of the RETINA called the MACULA LUTEA. It is distinguishable from WET MACULAR DEGENERATION in that the latter involves neovascular exudates.

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