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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02320812
Other study ID # JC-01
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date June 2015
Est. completion date July 19, 2017

Study information

Verified date March 2019
Source jCyte, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date July 19, 2017
Est. primary completion date July 19, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
human retinal progenitor cells
single intravitreal injection of 0.5 - 3.0 million human retinal progenitor cells (hRPC)

Locations

Country Name City State
United States The Gavin Herbert Eye Institute, Univ California Irvine Irvine California
United States Retina-Vitreous Associates Medical Group Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
jCyte, Inc California Institute for Regenerative Medicine (CIRM)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Subjects With Adverse Events as a Measure of Safety and Tolerability proportion of subjects with treatment emergent adverse events (TEAE), related TEAE and severe TEAE 12 months
Secondary Change in Mean Best Corrected Visual Acuity (BCVA) 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. 12 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03975543 - Retrospective Natural History Study of Retinitis Pigmentosa
Recruiting NCT04763369 - Investigation of Therapeutic Efficacy and Safety of UMSCs for the Management of Retinitis Pigmentosa (RP) Phase 2
Completed NCT01543906 - Oral QLT091001 in Retinitis Pigmentosa (RP) Subjects With an Autosomal Dominant Mutation in Retinal Pigment Epithelial 65 Protein (RPE65) Phase 1
Completed NCT02575430 - Natural History Study in Inherited Retinal Disease Subjects Caused by Mutations in RPE65 or LRAT N/A