Actively Recruiting
Safety of a Single, Intravitreal Injection of 6.0M jCell (Famzeretcel) in Retinitis Pigmentosa (RP)
Led by jCyte, Inc · Updated on 2026-04-13
60
Participants Needed
14
Research Sites
62 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety of a Single, Intravitreal Injection of 6.0M jCell (Famzeretcel) in Retinitis Pigmentosa (RP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of Retinitis Pigmentosa supported by at least two clinical findings such as peripheral vision loss, night blindness, or retinal atrophy
- Electroretinography results or genetic testing supporting diagnosis of RP
- Age between 18 and 60 years at consent
- Interocular best corrected visual acuity (BCVA) difference of 15 letters or less
- Central subfield thickness of 130 micrometers or more in the study eye
- BCVA in the study eye between 1 and 55 letters using ETDRS testing
- Ability to fixate reliably with the study eye at least 75% of the time
- Ability to record at least two reliable contrast sensitivity trials at baseline using the Beethoven system
- Central island visual field area of 50.3 degrees squared or more in the study eye
- Willingness to provide informed consent and comply with study visits
- Willingness to provide blood samples for HLA typing if not previously done
- Willingness to consent to RP gene mutation testing if not previously performed
- Adequate organ function
- Negative active infection screen for Hepatitis B, C, and HIV
- Negative pregnancy test for women of childbearing potential before treatment
- Agreement to use medically accepted contraception for 12 months after injection for women of childbearing potential
- Male participants with partners of childbearing potential agree to use medically accepted contraception
You will not qualify if you...
- Participation in another drug clinical trial within the last 6 months (except N-acetyl cysteine studies)
- History of ocular treatment with experimental or investigational therapies or devices, including prior jCyte trials
- Currently breastfeeding or planning to breastfeed within 12 months after treatment
- Currently pregnant or planning pregnancy within 12 months after treatment
- Known allergy to gentamicin
- History of adverse reaction to dimethyl sulfoxide (DMSO)
- Prior corticosteroid eye treatment within 6 months or anticipated need for corticosteroids
- History of eye diseases other than RP that could impair vision or study measurements
- Concurrent use of prohibited therapies
- History of specific medications if retinal abnormalities are present
- Mental health conditions that interfere with study compliance
- Uncontrolled blood pressure above specified limits
- Chronic systemic disease requiring steroids or immunosuppressants
- Diseases interfering with study participation including uncontrolled cancer, diabetes, renal failure, stroke, immune or coagulation disorders
- Current systemic treatment for active infection
- Male participants unwilling to use contraception if partners are of childbearing potential
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Associated Retina Consultants
Phoenix, Arizona, United States, 85020
Actively Recruiting
2
California Retina Consultants
Bakersfield, California, United States, 93309
Actively Recruiting
3
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90074
Actively Recruiting
4
Gavin Herbert Eye Institute, UC Irvine
Irvine, California, United States, 92697
Actively Recruiting
5
Retina Consultants Medical Group
Sacramento, California, United States, 95825
Actively Recruiting
6
Bay Area Retina Associates
Walnut Creek, California, United States, 94598
Actively Recruiting
7
Vitreo Retinal Associates
Gainesville, Florida, United States, 32607
Actively Recruiting
8
Georgia Retina
Marietta, Georgia, United States, 30060
Actively Recruiting
9
Illinois Retina Associates
Oak Park, Illinois, United States, 60304
Actively Recruiting
10
NJRetina
Teaneck, New Jersey, United States, 07666
Actively Recruiting
11
Long Island Vitreoretinal Consultants
Westbury, New York, United States, 11590
Actively Recruiting
12
Retina Consultants of Texas: Bellaire Retina Center
Bellaire, Texas, United States, 77401
Actively Recruiting
13
Retina Consultants of Texas: San Antonio
San Antonio, Texas, United States, 78240
Actively Recruiting
14
The Retina Group of Washington
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
J
jCyte Sr. Director of Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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