NCT06912633

Safety of a Single, Intravitreal Injection of 6.0M jCell (Famzeretcel) in Retinitis Pigmentosa (RP)

A Randomized, Masked, Sham-Controlled Phase 2 Trial of the Safety of a Single Intravitreal Injection of jCell (Famzeretcel) for the Treatment of Retinitis Pigmentosa (RP)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: jCyte, Inc · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

• Retinitis Pigmentosa

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-20
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2025-04-06
• Last updated: 2026-04-13

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study