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)
jCyte, Inc
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.
Eligibility
- Age range
- 18–60 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Clinical diagnosis of RP supported by at least 2 of the following clinical findings: (1) Loss of peripheral vision on formal visual field testing, (2) Symptoms of night blindness or difficulty adjusting to dim light, or (3) Optical coherence tomography (OCT) outer retinal atrophy consistent with RP. 2. Electroretinography (ERG) results that support diagnosis of RP including nondetectable or severely reduced rod responses (defined as less than 30% of the lower limit of normative values for the ERG lab performing the test), with prolonged implicit time OU (i.e., ensure bi…
Interventions
- Biologicalhuman retinal progenitor cells
Single intravitreal injection of 6.0 million retinal progenitor cells (RPCs)
- OtherMock 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.
Locations (14)
- Associated Retina ConsultantsPhoenix, Arizona
- California Retina ConsultantsBakersfield, California
- Retina-Vitreous Associates Medical GroupBeverly Hills, California
- Gavin Herbert Eye Institute, UC IrvineIrvine, California
- Retina Consultants Medical GroupSacramento, California
- Bay Area Retina AssociatesWalnut Creek, California