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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
jCyte, Inc
Study ID
NCT06912633
Phase
PHASE2
Status
Recruiting
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Conditions

  • Retinitis Pigmentosa

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • human retinal progenitor cells — BIOLOGICAL
    Single intravitreal injection of 6.0 million retinal progenitor cells (RPCs)
  • Mock injection — OTHER
    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.

Study Details

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.

Key Dates

Start date
Jun 20, 2025
Status verified
Feb 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 6.0M jCell injection
    Single intravitreal injection of 6.0 million retinal progenitor cells into the study eye
  • Sham Comparator: Sham-treated control
    A mock injection will be performed on the study eye in each control subject

Primary Outcome Measure

Safety of Intravitreal Injection of 6.0M jCell [ Time Frame: 6 months ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
Associated Retina ConsultantsPhoenixArizona85020
Jillian Bollinger
[email protected]
480-999-5458
Benjamin Bakall, MD, PhD (PRINCIPAL_INVESTIGATOR)
California Retina ConsultantsBakersfieldCalifornia93309
Brandy Plaat
[email protected]
805-568-7547
Dante Pieramici, MD, FASRS (PRINCIPAL_INVESTIGATOR)
Retina-Vitreous Associates Medical GroupBeverly HillsCalifornia90074
Clinical Trials Coordinator
[email protected]
310-289-2478
David Liao, MD, PhD (PRINCIPAL_INVESTIGATOR)
Gavin Herbert Eye Institute, UC IrvineIrvineCalifornia92697
Study Coordinator
[email protected]
949-824-2020
Mitul Mehta, MD, MS (PRINCIPAL_INVESTIGATOR)
Retina Consultants Medical GroupSacramentoCalifornia95825
Joshua Greenwood
[email protected]
916-974-9279
David Telander, MD, PhD (PRINCIPAL_INVESTIGATOR)
Bay Area Retina AssociatesWalnut CreekCalifornia94598
Luis Monsalve
[email protected]
925-265-4146
Roger Goldberg, MD (PRINCIPAL_INVESTIGATOR)
Vitreo Retinal AssociatesGainesvilleFlorida32607
Jing Zhang
[email protected]
352-300-8412
Christine Kay, MD (PRINCIPAL_INVESTIGATOR)
Georgia RetinaMariettaGeorgia30060
Blair Symington
[email protected]
770-218-1888
David Chin Yee, MD (PRINCIPAL_INVESTIGATOR)
Illinois Retina AssociatesOak ParkIllinois60304
Jamie Matute
[email protected]
833-538-1216
Mathew W MacCumber, MD, PhD (PRINCIPAL_INVESTIGATOR)
NJRetinaTeaneckNew Jersey07666
Benjamin Outten
[email protected]
201-837-7300
Luis Gonzalez, MD (PRINCIPAL_INVESTIGATOR)
Long Island Vitreoretinal ConsultantsWestburyNew York11590
Ewelina Lokaj
[email protected]
516-466-0390
Philip Ferrone, MD (PRINCIPAL_INVESTIGATOR)
Retina Consultants of Texas: Bellaire Retina CenterBellaireTexas77401
Study Coordinator
[email protected]
(713) 524-3434
Kenneth Fan, MD (PRINCIPAL_INVESTIGATOR)
Retina Consultants of Texas: San AntonioSan AntonioTexas78240
Lydia Adams
[email protected]
210-903-1046
Jeremiah Brown, MD (PRINCIPAL_INVESTIGATOR)
The Retina Group of WashingtonFairfaxVirginia22031
Katrina Arias
[email protected]
703-698-9335
Joshua Levinson, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Associated Retina Consultants· Phoenix, AZCalifornia Retina Consultants· Bakersfield, CARetina-Vitreous Associates Medical Group· Beverly Hills, CAGavin Herbert Eye Institute, UC Irvine· Irvine, CARetina Consultants Medical Group· Sacramento, CABay Area Retina Associates· Walnut Creek, CA

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