drugset / Trial / NCT03073733
Safety and Efficacy of Intravitreal Injection of Human Retinal Progenitor Cells in Adults With Retinitis Pigmentosa
Phase 2
Completed
84 enrolled
jCyte, Inc
California Institute for Regenerative Medicine (CIRM) · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
This study evaluates the changes in visual function at 12 months following a single injection of human retinal progenitor cells compared to sham treated controls in a cohort of adult subjects with RP.
Timeline
- Start
- 2017-03-01
- Primary completion
- 2020-11-13
- Completion
- 2020-11-13
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
registry p = 0.582; least squares mean difference -2.2 (95% CI -10.3 to 5.8) reads as missed primary endpoint NCT03073733 ↗
release “had an early, sustained, and significant mean improvement in the primary endpoint of best corrected visual acuity” reads as met primary endpoint jcyte.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | human retinal progenitor cells | Cell therapy | 3 cells | Intravitreal |
| Subject | human retinal progenitor cells | Cell therapy | 6 cells | Intravitreal |