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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
jCyte, Inc
ClinicalTrials.gov Identifier:
NCT02320812
First received: December 16, 2014
Last updated: August 15, 2017
Last verified: March 2017
  Purpose
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. Two different dose levels of cells will be assessed in each of two groups of patients.

Condition Intervention Phase
Retinitis Pigmentosa (RP) Biological: human retinal progenitor cells Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by jCyte, Inc:

Primary Outcome Measures:
  • Number of subjects with adverse events as a measure of safety and tolerability [ Time Frame: 12 months ]
    adverse events, with emphasis on ophthalmic adverse events


Secondary Outcome Measures:
  • Effect of treatment on ocular function [ Time Frame: 12 months ]
    as assessed by best corrected visual acuity

  • Effect of treatment on ocular function [ Time Frame: 12 months ]
    as assessed by optical coherence tomography

  • Effect of treatment on ocular function [ Time Frame: 12 months ]
    as assessed by electroretinogram

  • Effect of treatment on ocular function [ Time Frame: 12 months ]
    as assessed by visual field testing, if applicable

  • Effect of treatment on ocular function [ Time Frame: 12 months ]
    as assessed by fluorescein angiography


Enrollment: 28
Study Start Date: June 2015
Study Completion Date: July 19, 2017
Primary Completion Date: July 19, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treated subjects
human retinal progenitor cells
Biological: human retinal progenitor cells
single intravitreal injection of 0.5 - 3.0 million human retinal progenitor cells (hRPC)
Other Name: jCell

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of RP confirmed by 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 HM (hand motions)
  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02320812

Locations
United States, California
The Gavin Herbert Eye Institute, Univ California Irvine
Irvine, California, United States
Retina-Vitreous Associates Medical Group
Los Angeles, California, United States, 90074
Sponsors and Collaborators
jCyte, Inc
  More Information

Responsible Party: jCyte, Inc
ClinicalTrials.gov Identifier: NCT02320812     History of Changes
Other Study ID Numbers: JC-01
Study First Received: December 16, 2014
Last Updated: August 15, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Retinitis
Retinitis Pigmentosa
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on September 19, 2017