Safety of Repeat Intravitreal Injection of Human Retinal Progenitor Cells (jCell) in Adult Subjects With Retinitis Pigmentosa
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|ClinicalTrials.gov Identifier: NCT04604899|
Recruitment Status : Completed
First Posted : October 27, 2020
Last Update Posted : August 10, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Retinitis Pigmentosa||Biological: human retinal progenitor cells||Phase 2|
This is a prospective, multi-center, single arm, Phase 2 study of human retinal progenitor cells (jCell) for the treatment of retinitis pigmentosa (RP). The study will include only subjects previously treated with jCell.
To assess reinjection of a previously treated eye, subjects who have previously been treated with jCell and desire a second treatment in the same eye will be enrolled. Subjects must have completed at least 12 months of follow up since the prior injection of jCell. Subjects who have had both eyes previously treated with jCell will only have one eye retreated; the eye to be retreated will preferably be the better seeing eye, but exceptions may be made by the study investigator, taking into consideration BCVA, prior response to treatment, and any other medical conditions that may indicate which eye is the best candidate for retreatment. Subjects will be followed for 12 months for safety and efficacy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of the Safety of Repeat Intravitreal Injection of Human Retinal Progenitor Cells (jCell) in Adult Subjects With Retinitis Pigmentosa (RP)|
|Actual Study Start Date :||December 1, 2020|
|Actual Primary Completion Date :||March 22, 2022|
|Actual Study Completion Date :||March 22, 2022|
Experimental: Retreated subjects
Subjects receiving human retinal progenitor cells (jCell) who have previously received jCell is a jCyte study.
Biological: human retinal progenitor cells
single intravitreal injection of 6.0 million human retinal progenitor cells (hRPC)
Other Name: jCell
- Safety of intravitreal injection of hRPC [ Time Frame: 12 months ]Assessed by proportion of subjects with treatment emergent adverse events
- Best corrected visual acuity [ Time Frame: 12 months ]Assessed by E-ETDRS
- Visual fields [ Time Frame: 12 months ]The Octopus 900 will be used for kinetic visual field testing using a specified target of V4e for more severe subjects and a target of III4e and V4e for better seeing subjects
- Contrast sensitivity [ Time Frame: 12 months ]The Beethoven System will be used to capture the peak mean contrast sensitivity threshold value at any given spatial frequency
- Mobility [ Time Frame: 12 months ]Maze testing
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Willing to give written informed consent, able to make the required study visits and follow study protocol instructions.
- Completed the 12 months of follow up in the subject's most recent jCell study and did not withdraw from the study for any reason.
Adequate organ function:
- blood counts (hematocrit, Hgb, WBC, platelets and differential) within normal range, or if outside of normal range, not clinically significant as judged by the investigator
- liver function: alanine transaminase [ALT] and aspartate transaminase [AST] ≤2 times the upper limit of the normal range
- total bilirubin ≤1.5 times the upper limit of the normal range
- renal function: serum creatinine ≤1.25 times the upper limit of the normal range
- A female patient of childbearing potential (not surgically sterilized and less than one year postmenopausal) must have a negative pregnancy test (urine human chorionic gonadotropin) at entry (prior to injection) and must have used medically accepted contraception for at least one month prior to treatment. Women of childbearing potential and men must be advised to use a medically accepted method of contraception for at least 12 months following treatment.
- Malignancy, end-stage major organ disease (heart failure, significant arrhythmias, stroke or transient ischemic attacks, diabetes, immunosuppressive or autoimmune state, major psychiatric disorder, epilepsy, thyroid disease, COPD, renal failure, or any chronic systemic disease requiring continuous treatment with systemic steroids, anticoagulants or immunosuppressive agents.
- History of eye disease other than RP that impairs visual function, including retinal vascular disease, elevated intraocular pressure/glaucoma, severe posterior uveitis, clinically significant macular edema, media opacity precluding visual exam, amblyopia and/or longstanding constant strabismus, as well as patients who require other intravitreal therapies
- Allergy to penicillin or streptomycin.
- Adverse reaction to DMSO.
- Unable or unwilling to undergo pupil dilation, topical anesthesia or any protocol-required procedure.
- Women who are nursing or who are planning to nurse during the 12 months that would follow study treatment.
- Any circumstance that in the opinion of the investigator, would interfere with participation in, or compliance with the study protocol
- Treatment with corticosteroids (systemic, periocular or intravitreal) or any other non-approved, experimental, investigational or neuroprotectant therapy (systemic, topical, intravitreal) in either eye within 90 days of planned second injection.
- Cataract surgery within three months prior to treatment or anticipated to need cataract surgery within a year of treatment
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): NCT04604899
|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:||Mitul Mehta, MD||University of California, Irvine/Gavin Herbert Eye Institute|
|Principal Investigator:||David Liao, MD||Retina-Vitreous Associates Medical Group, Los Angeles CA|
|Principal Investigator:||Anthony Jospeh, MD||Ophthalmic Consultants of Boston|
|Responsible Party:||jCyte, Inc|
|Other Study ID Numbers:||
|First Posted:||October 27, 2020 Key Record Dates|
|Last Update Posted:||August 10, 2022|
|Last Verified:||August 2022|
|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|
Eye Diseases, Hereditary
Genetic Diseases, Inborn