Safety of a Single, Intravitreal Injection of 6.0M jCell (Famzeretcel) in Retinitis Pigmentosa (RP)
NCT06912633 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-04-13
Summary
This study evaluates the safety of a single injection of jCell (famzeretcel) comprising 6.0 million (6.0M) retinal progenitor cells over a six-month study period in a cohort of adult subjects with RP. Additionally, changes in visual function will be evaluated at six months between the active treatment group (6.0M jCell) compared to sham-treated controls.
Conditions
Interventions
- BIOLOGICAL
-
human retinal progenitor cells
Single intravitreal injection of 6.0 million retinal progenitor cells (RPCs)
- OTHER
-
Mock injection
Pressing the hub of a syringe with no needle against the eye to mimic intravitreal injection. Subjects randomized to the sham control group will undergo identical preparation as the active treatment group immediately prior to treatment, including application of anesthetics.
Sponsors & Collaborators
-
jCyte, Inc
lead INDUSTRY
Principal Investigators
-
Henry Klassen, MD, PhD · jCyte, Inc
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-20
- Primary Completion
- 2026-09-30
- Completion
- 2026-09-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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