NCT02320812

Safety of a Single, Intravitreal Injection of Human Retinal Progenitor Cells (jCell) in Retinitis Pigmentosa

A Prospective, Multicenter, Open-Label, Single-Arm Study of the Safety and Tolerability of a Single, Intravitreal Injection of Human Retinal Progenitor Cells (jCell) in Adult Subjects With Retinitis Pigmentosa (RP)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: jCyte, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the safety and potential activity of a single dose of live human retinal progenitor cells (jCell) administered to adults with retinitis pigmentosa. Four different dose levels of cells will be assessed in each of two groups of patients.

Detailed description

The primary purpose of this study is to test the safety and tolerability of the administration of a single dose of jCell to adults with retinitis pigmentosa. The goal of jCell therapy is to preserve vision by intervening in the disease at a time when host photoreceptors can be protected and potentially reactivated. Human allogeneic retinal progenitor cells will be injected into adults with advanced RP to see if the procedure is safe, if the cells survive, and whether they have any impact on the visual status of the patients.

Conditions

• Retinitis Pigmentosa (RP)

Interventions

Type	Name	Description
BIOLOGICAL	human retinal progenitor cells	single intravitreal injection of 0.5 - 3.0 million human retinal progenitor cells (hRPC)

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-07-19
• Completion: 2017-07-19
• First posted: 2014-12-19
• Last updated: 2019-03-05
• Results posted: 2019-03-05

Locations

2 sites across 1 country: United States