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| Name | Class |
|---|---|
| California Institute for Regenerative Medicine (CIRM) | OTHER |
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This study evaluates the safety and potential activity of a single dose of live human retinal progenitor cells (jCell) administered to adults with retinitis pigmentosa. Four different dose levels of cells will be assessed in each of two groups of patients.
The primary purpose of this study is to test the safety and tolerability of the administration of a single dose of jCell to adults with retinitis pigmentosa.
The goal of jCell therapy is to preserve vision by intervening in the disease at a time when host photoreceptors can be protected and potentially reactivated.
Human allogeneic retinal progenitor cells will be injected into adults with advanced RP to see if the procedure is safe, if the cells survive, and whether they have any impact on the visual status of the patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated subjects | Experimental | human retinal progenitor cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| human retinal progenitor cells | Biological | single intravitreal injection of 0.5 - 3.0 million human retinal progenitor cells (hRPC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Adverse Events as a Measure of Safety and Tolerability | proportion of subjects with treatment emergent adverse events (TEAE), related TEAE and severe TEAE | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Best Corrected Visual Acuity (BCVA) | change in mean best corrected visual acuity in test eye versus untreated eye; BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. Change between baseline and month 12 is reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Baruch Kuppermann, MD | Gavin Herbert Eye Institute, UCI, Irvine, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Gavin Herbert Eye Institute, Univ California Irvine | Irvine | California | United States | |||
| Retina-Vitreous Associates Medical Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40927136 | Derived | Yang J, Kuppermann BD, Liao D, Mehta MC, Hsiang C, Menges S, Boyer DS, Klassen H. Retinal progenitor cells (jCell) for retinitis pigmentosa. Front Cell Neurosci. 2025 Aug 25;19:1646156. doi: 10.3389/fncel.2025.1646156. eCollection 2025. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treated Subjects | human retinal progenitor cells human retinal progenitor cells: single intravitreal injection of 0.5 - 3.0 million human retinal progenitor cells (hRPC) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treated Subjects | human retinal progenitor cells human retinal progenitor cells: single intravitreal injection of 0.5 - 3.0 million human retinal progenitor cells (hRPC) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Adverse Events as a Measure of Safety and Tolerability | proportion of subjects with treatment emergent adverse events (TEAE), related TEAE and severe TEAE | all treated subjects | Posted | Count of Participants | Participants | 12 months |
|
|
one year following single intravitreal injection of hRPC
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treated Subjects | human retinal progenitor cells human retinal progenitor cells: single intravitreal injection of 0.5 - 3.0 million human retinal progenitor cells (hRPC) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| migratory pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | Grade 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anterior chamber flare | Eye disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Terry O'Neal, Chief Operating Officer | jCyte, Inc | 949-243-0688 | terry.oneal@jcyte.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 7, 2016 | Aug 6, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 8, 2017 | Aug 6, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012174 | Retinitis Pigmentosa |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D058499 | Retinal Dystrophies |
| D012162 | Retinal Degeneration |
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| 12 months |
| Los Angeles |
| California |
| 90074 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Change in Mean Best Corrected Visual Acuity (BCVA) | change in mean best corrected visual acuity in test eye versus untreated eye; BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. Change between baseline and month 12 is reported. | all treated subjects | Posted | Mean | Full Range | number of letters read correctly | 12 months |
|
|
|
| 0 |
| 28 |
| 1 |
| 28 |
| 20 |
| 28 |
|
| conjunctival hemorrhage | Eye disorders | MedDRA | Systematic Assessment |
|
| eye pain | Eye disorders | MedDRA | Systematic Assessment |
|
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| D012164 |
| Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |