Safety and Efficacy of Intravitreal Injection of Human Retinal Progenitor Cells in Adults With Retinitis Pigmentosa

• Register: ClinicalTrials.gov
• Last refreshed on: 17 May 2021
• Main ID: NCT03073733
• Date of registration: 02/03/2017
• Prospective Registration: No
• Primary sponsor: jCyte, Inc
• Public title: Safety and Efficacy of Intravitreal Injection of Human Retinal Progenitor Cells in Adults With Retinitis Pigmentosa
• Scientific title: A Prospective, Multicenter, Randomized, Study of the Safety and Efficacy of Intravitreal Injection of Human Retinal Progenitor Cells (jCell) in Adult Subjects With Retinitis Pigmentosa (RP)
• Date of first enrolment: March 1, 2017
• Target sample size: 84
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03073733
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Barruch Kuppermann, MD
• Affiliation: UCI

Key inclusion & exclusion criteria

Inclusion Criteria:

Clinical diagnosis of RP confirmed by ERG and willing to consent to mutation typing, if not
already done Best corrected visual acuity (BCVA) 20/80 or worse and no worse than 20/800
Adequate organ function and negative infectious disease screen Female of childbearing
potential must have negative pregnancy test and be willing to use medically accepted
methods of contraception throughout the study

Exclusion Criteria:

Eye disease other than RP that impairs visual function Pseudo-RP, cancer-associated
retinopathies History of malignancy or other end-stage organ disease, or any chronic
disease requiring continuous treatment with system steroids, anticoagulants or
immunosuppressive agents Known allergy to penicillin or streptomycin Treatment with
corticosteroids or any investigational or neuroprotectant therapy within 90 days of
enrollment Cataract surgery within 3 months prior to enrollment



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Retinitis Pigmentosa

Intervention(s)

Other: Mock injection

Biological: human retinal progenitor cells

Primary Outcome(s)

best corrected visual acuity [Time Frame: 12 months]

Secondary Outcome(s)

safety of intravitreal injection of hRPC [Time Frame: 12 months]

visual fields [Time Frame: 12 months]

contrast sensitivity [Time Frame: 12 months]

effect of treatment on functional vision [Time Frame: 12 months]

mobility [Time Frame: 12 months]

Secondary ID(s)

JC-02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

California Institute for Regenerative Medicine (CIRM)