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

Completed · Phase 1/Phase 2

Conditions studied: Retinitis Pigmentosa (RP)

In brief

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.

Key facts

Study ID

NCT02320812

Run by

jCyte, Inc

People needed

28

Starts

2015-06-01

Expected to finish

2017-07-19

Last updated by the study team

2019-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of RP confirmed by electroretinogram (ERG) and willing to consent to mutation typing, if not already done
• Best corrected visual acuity (BCVA) 20/63 or worse and no worse than hand motions (HM)
• Adequate organ function and negative infectious disease screen
• Female of childbearing potential must have negative pregnancy test and be willing to use medically accepted methods of contraception throughout the study

You may not qualify if…

• Eye disease other than RP that impairs visual function
• Pseudo-RP, cancer-associated retinopathies
• History of malignancy or other end-stage organ disease, or any chronic disease requiring continuous treatment with system steroids, anticoagulants or immunosuppressive agents
• Known allergy to penicillin or streptomycin

Where it is running

• The Gavin Herbert Eye Institute, Univ California Irvine — Irvine, California, United States
• Retina-Vitreous Associates Medical Group — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.