Retinitis Pigmentosa (RP) Clinical Trial
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)
Verified date | March 2019 |
Source | jCyte, Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
jCyte, Inc | California Institute for Regenerative Medicine (CIRM) |
United States,
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 |
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