Phase 2
N=28
Safety of a Single, Intravitreal Injection of Human Retinal Progenitor Cells (jCell) in Retinitis Pigmentosa
Retinitis Pigmentosa (RP)
Bottom Line
View on ClinicalTrials.gov: NCT02320812 ↗Enrolled (actual)
28
Serious AEs
3.6%
Results posted
Mar 2019
Primary outcome: Primary: Number of Subjects With Adverse Events as a Measure of Safety and Tolerability — 25; 21; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- human retinal progenitor cells (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- jCyte, Inc
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Adverse Events as a Measure of Safety and Tolerability |
25; 21; 1 | — |
| SECONDARY Change in Mean Best Corrected Visual Acuity (BCVA) |
1.4; 1.0; 4.8; 9.0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02320812). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.