Safety and Efficacy of Intravitreal Injection of Human Retinal Progenitor Cells in Adults With Retinitis Pigmentosa
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ClinicalTrials.gov Identifier: NCT03073733 |
Recruitment Status :
Active, not recruiting
First Posted : March 8, 2017
Last Update Posted : February 17, 2021
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Condition or disease | Intervention/treatment | Phase |
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Retinitis Pigmentosa | Biological: human retinal progenitor cells Other: Mock injection | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 84 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Masking Description: | Subjects, their family members and clinical staff performing key efficacy assessments will be masked to the randomization assignment of subjects. Due to the nature of some safety assessments and the sham treatment, not all personnel can be masked. |
Primary Purpose: | Treatment |
Official 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) |
Actual Study Start Date : | March 1, 2017 |
Actual Primary Completion Date : | November 13, 2020 |
Estimated Study Completion Date : | March 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Test (jCell injection) dose level 1
single intravitreal injection of 3.0 x 10e6 human retinal progenitor cells into the eye with the poorest visual acuity or, if vision is comparable in both eyes, the non-dominant eye
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Biological: human retinal progenitor cells
live suspension of 3.0 or 6.0 x 10e6 human retinal progenitor cells (hRPC) suspended in clinical grade medium injected intravitreally under local anesthesia
Other Name: jCell |
Sham treated Control
a mock injection will be performed on the eye with the poorest vision in each Control subject (designated as the "study eye")
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Other: Mock injection
pressing the hub of a syringe with no needle against the eye to mimic intravitreal injection |
Experimental: test (jCell injection) dose level 2
single intravitreal injection of 6.0 x 10e6 human retinal progenitor cells into the eye with the poorest visual acuity or, if vision is comparable in both eyes, the non-dominant eye
|
Biological: human retinal progenitor cells
live suspension of 3.0 or 6.0 x 10e6 human retinal progenitor cells (hRPC) suspended in clinical grade medium injected intravitreally under local anesthesia
Other Name: jCell |
- best corrected visual acuity [ Time Frame: 12 months ]assessed by E-ETDRS
- mobility [ Time Frame: 12 months ]maze testing
- effect of treatment on functional vision [ Time Frame: 12 months ]assessed by visual quality of life evaluation
- visual fields [ Time Frame: 12 months ]Goldmann
- contrast sensitivity [ Time Frame: 12 months ]assessment of the ability to distinguish between finer and finer increments of light versus dark (contrast)
- safety of intravitreal injection of hRPC [ Time Frame: 12 months ]assessed by treatment emergent adverse events, immunogenicity and safety visual assessments

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03073733
United States, California | |
Gavin Herbert Eye Inst, Univ Cal Irvine | |
Irvine, California, United States, 92697 | |
Retina-Vitreous Associates Medical Group | |
Los Angeles, California, United States, 90074 | |
United States, Massachusetts | |
Ophthalmic Consultants of Boston | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Barruch Kuppermann, MD | UCI |
Responsible Party: | jCyte, Inc |
ClinicalTrials.gov Identifier: | NCT03073733 |
Other Study ID Numbers: |
JC-02 |
First Posted: | March 8, 2017 Key Record Dates |
Last Update Posted: | February 17, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Retinitis Retinitis Pigmentosa Retinal Diseases Eye Diseases |
Eye Diseases, Hereditary Retinal Dystrophies Retinal Degeneration Genetic Diseases, Inborn |