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Safety and Tolerability of hRPC in Retinitis Pigmentosa — hRPCRP  

Retinitis Pigmentosa Clinical Trial

Official title:
First-in-human Phase I/IIa, Open-Label, Prospective Study of the Safety and Tolerability of Subretinally Transplanted Human Retinal Progenitor Cells (hRPC) in Patients With Retinitis Pigmentosa (RP)

Clinical Trial Summary

hRPC is a cell therapy for retinitis pigmentosa. This is a first-in-human, dose escalation study in which participants with retinitis pigmentosa will receive a single subretinal injection of hRPC cells in one eye to evaluate safety and tolerability. Participants will be followed for two years to evaluate the safety and tolerability of hRPC Additional testing will seek to establish any preliminary efficacy from hRPC.

Clinical Trial Description

This is a first-in-human open label phase I/II dose-escalation study in which participants with retinitis pigmentosa will receive a single uni-ocular subretinal implantation of one of three doses of hRPC. Treated eyes will be carefully monitored for any ocular or systemic adverse events for 2 years. Testing will comprise a series of detailed ophthalmic examinations and imaging together with blood testing and systemic evaluations, as necessary. Ophthalmic testing will also be evaluated for any preliminary efficacy signal. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02464436
Study type Interventional
Source ReNeuron Limited
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date December 2015
Completion date December 2023
View Details
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