Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02320812
Recruitment Status : Completed
First Posted : December 19, 2014
Results First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Collaborator:
California Institute for Regenerative Medicine (CIRM)
Information provided by (Responsible Party):
jCyte, Inc

Tracking Information
First Submitted Date  ICMJE December 16, 2014
First Posted Date  ICMJE December 19, 2014
Results First Submitted Date  ICMJE August 7, 2018
Results First Posted Date  ICMJE March 5, 2019
Last Update Posted Date March 5, 2019
Study Start Date  ICMJE June 2015
Actual Primary Completion Date July 19, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2019)
Number of Subjects With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 12 months ]
proportion of subjects with treatment emergent adverse events (TEAE), related TEAE and severe TEAE
Original Primary Outcome Measures  ICMJE
 (submitted: December 16, 2014)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2019)
Change in Mean Best Corrected Visual Acuity (BCVA) [ Time Frame: 12 months ]
change in mean best corrected visual acuity in test eye versus untreated eye; BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. Change between baseline and month 12 is reported.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2014)
Effect of treatment on ocular function [ Time Frame: 12 months ]
Best corrected visual acuity, Optical Coherence Tomography, Electroretinogram, Visual Field Testing, Fluorescein Angiography
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of a Single, Intravitreal Injection of Human Retinal Progenitor Cells (jCell) in Retinitis Pigmentosa
Official Title  ICMJE 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)
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Retinitis Pigmentosa (RP)
Intervention  ICMJE Biological: human retinal progenitor cells
single intravitreal injection of 0.5 - 3.0 million human retinal progenitor cells (hRPC)
Other Name: jCell
Study Arms  ICMJE Experimental: Treated subjects
human retinal progenitor cells
Intervention: Biological: human retinal progenitor cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 10, 2016)
28
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2014)
16
Actual Study Completion Date  ICMJE July 19, 2017
Actual Primary Completion Date July 19, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02320812
Other Study ID Numbers  ICMJE JC-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party jCyte, Inc
Study Sponsor  ICMJE jCyte, Inc
Collaborators  ICMJE California Institute for Regenerative Medicine (CIRM)
Investigators  ICMJE
Principal Investigator: Baruch Kuppermann, MD Gavin Herbert Eye Institute, UCI, Irvine, CA
PRS Account jCyte, Inc
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP