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Evaluating the safety of a single injection of retinal progenitor cells in patients with Retinitis Pigmentosa

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)

Phase 2 Interventional jCyte, Inc · NCT06912633

This study is testing whether a single injection of retinal cells is safe for adults with Retinitis Pigmentosa and if it can help improve their vision.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment60 (estimated)
Ages18 Years to 60 Years
SexAll
SponsorjCyte, Inc Industry-sponsored
Locations14 sites (Phoenix, Arizona and 13 other locations)
Trial IDNCT06912633 on ClinicalTrials.gov

What this trial studies

This study assesses the safety of a single intravitreal injection of 8.8 million retinal progenitor cells (jCell) in adults diagnosed with Retinitis Pigmentosa (RP). Over a six-month period, participants will receive either the active treatment or a sham injection, with evaluations focusing on changes in visual function. The study aims to determine the safety profile of the treatment and its potential effects on vision. Participants will be monitored for any adverse effects and improvements in visual capabilities.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 60 with a clinical diagnosis of Retinitis Pigmentosa and specific visual function criteria.

Not a fit: Patients with advanced stages of Retinitis Pigmentosa or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for improving vision in patients with Retinitis Pigmentosa.

How similar studies have performed: While there have been studies on retinal progenitor cells, this specific approach is novel and has not been extensively tested in this context.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 bilateral involvement) and greater rod than cone loss. If genotyping results from a certified genetic testing lab document mutations clearly diagnostic of RP, with no other potential diagnosis of a disease(s) distinct from RP, the genetic test may be used in lieu of an ERG.
3. Subject age ≥ 18 years and ≤ 60 years at time of signing of consent.
4. Interocular BCVA disparity ≤ 15 letters.
5. Central subfield thickness (CST) ≥ 130 µm in the study eye.
6. BCVA no better than 55 letters and no worse than 1 letter using the Early Treatment Diabetic Retinopathy Study (ETDRS) testing protocol in the study eye.
7. Ability to reliably fixate with the study eye at least 75% of the time as indicated by a fixation score of four (4) or five (5) on semi-automated kinetic visual fields.
8. Ability to record at least two reliable trials at a minimum baseline contrast sensitivity reading of 1.28 at a minimum of one spatial frequency using the Beethoven system in the study eye.
9. Central island visual field area (central island contiguous to fixation), of ≥ 50.3 deg2 (\~ central island visual field diameter ≥ 8°) in the study eye.
10. Willingness of subject to provide informed consent, including acknowledgement that they are able and willing to attend all required study visits, follow study protocol assessment instructions, travel by air if necessary, and provide Health Insurance Portability and Accountability Act (HIPAA) authorization.
11. Willingness of subject to provide a blood sample for human leukocyte antigen (HLA) typing, if not done previously with available results.
12. Willingness of subject to consent to testing for RP gene mutation typing, if not performed previously with available results.
13. Adequate organ function.
14. Negative active infectious disease screen (active infection with Hepatitis B, C, human immunodeficiency virus \[HIV\]).
15. A female subject of childbearing potential must have a negative pregnancy test (urine human chorionic gonadotropin) at entry (prior to treatment).
16. Women of childbearing potential must agree to use a medically accepted method of contraception for at least 12 months after jCell injection.
17. For male patients whose partners are of child-bearing potential, willingness to use a medically accepted method of contraception.

Exclusion Criteria:

1. Participation in any clinical trial of a drug intervention within the last 6 months, with the exception of a N-acetyl cysteine (NAC) study.
2. History of ocular treatment with any non-approved, experimental, investigational or neuroprotectant therapy (systemic, topical, intravitreal) or device in either eye, including previous jCyte clinical trials. Individuals with a history of NAC treatment may take part in the study following a 7-day washout period (prior to Baseline testing).
3. Subject is currently breast feeding/pumping or is planning to breast feed/pump during the 12 months after study treatment.
4. Subject is pregnant or intends to become pregnant less than 12 months after jCell injection.
5. Known allergy to gentamicin.
6. History of adverse reaction to dimethyl sulfoxide (DMSO).
7. Prior ocular treatment with corticosteroids (systemic, periocular, intracanalicular or intravitreal - in either eye) within six months of study randomization or the anticipated need for the use of these agents to treat a pre-existing ocular condition.
8. Clinical evidence of history of any eye disease or pathology, other than RP, IN EITHER EYE, that is associated with increased risk of pathology developing in the study eye, that could impair visual function, testing procedures, clinical trial endpoint measurements and/or the outcome of the study. Examples include central serous retinopathy, vitreomacular traction, pattern/vitelliform dystrophy
9. Clinical evidence of history of any eye disease or pathology, other than RP, IN THE STUDY EYE, that could potentially impair visual function, testing procedures, clinical trial endpoint measurements and/or the outcome of the study.
10. Concurrent use of any prohibited therapies.
11. History of prior use of the following medications is prohibited if any retinal/retinal pigment epithelium (RPE) abnormalities are noted in the macula on exam or OCT: Hydroxychloroquine or chloroquine (Plaquenil); Pentosan polysulfate sodium \[PPS\] (Elmiron); and Interferon (Intron A, Roferon-A, IFN-alpha, alpha interferon).
12. Any mental health issue likely to prevent subject from reliably performing study testing and/or examinations including dementia, schizophrenia, bipolar disorders if not reliably controlled on medications, depression if any history of hospitalization or in-patient treatment or if not sufficiently controlled on medications to enable, in the opinion of the investigator, travel to and compliance with study testing requirements over the study period.
13. Uncontrolled blood pressure defined as systolic pressure \> 180mmHg and/or diastolic blood pressure \> 110mmHg, while subject is at rest.
14. Any chronic systemic disease requiring continuous treatment with systemic steroids or immunosuppressive agents.
15. History of any disease interfering with the participation in the study according to the investigator judgment, including of any type of cancer that is not in remission or considered cured, diabetes mellitus (history of gestational diabetes is acceptable), renal failure, stroke, transient ischemic attack (TIA), any systemic immune condition, any coagulopathy disorder that is not adequately managed/controlled.
16. Current systemic treatment for a confirmed active infection.
17. For male patients whose co-partners are of child-bearing potential, lack of willingness to use a medically accepted method of contraception, not including the rhythm method, for at least 12 months after jCell injection.

Where this trial is running

Phoenix, Arizona and 13 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Retinitis Pigmentosa
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.