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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02320812 |
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Date of registration:
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16/12/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety of a Single, Intravitreal Injection of Human Retinal Progenitor Cells (jCell) in Retinitis Pigmentosa
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Scientific title:
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A Prospective, Multicenter, Open-Label, Single-Arm Study of the Safety and Tolerability of a Single, Intravitreal Injection of Human Retinal Progenitor Cells (jCell) in Adult Subjects With Retinitis Pigmentosa (RP) |
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Date of first enrolment:
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June 2015 |
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Target sample size:
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28 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02320812 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Baruch Kuppermann, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gavin Herbert Eye Institute, UCI, Irvine, CA |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Clinical diagnosis of RP confirmed by electroretinogram (ERG) and willing to consent
to mutation typing, if not already done
- Best corrected visual acuity (BCVA) 20/63 or worse and no worse than hand motions (HM)
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Retinitis Pigmentosa (RP)
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Intervention(s)
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Biological: human retinal progenitor cells
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Primary Outcome(s)
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Number of Subjects With Adverse Events as a Measure of Safety and Tolerability
[Time Frame: 12 months]
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Secondary Outcome(s)
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Change in Mean Best Corrected Visual Acuity (BCVA)
[Time Frame: 12 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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