Safety of Repeat Intravitreal Injection of Human Retinal Progenitor Cells (jCell) in Adult Subjects With Retinitis Pigmentosa

Completed · Phase 2

Conditions studied: Retinitis Pigmentosa

In brief

The primary objective of the study is to assess the safety of repeat injection of human retinal progenitor cells (jCell) in adult subjects with RP that have previously been treated with jCell.

Key facts

Study ID

NCT04604899

Run by

jCyte, Inc

People needed

30

Starts

2020-12-01

Expected to finish

2022-03-22

Last updated by the study team

2024-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Gavin Herbert Eye Inst, Univ Cal Irvine — Irvine, California, United States
• Retina-Vitreous Associates Medical Group — Los Angeles, California, United States
• Ophthalmic Consultants of Boston — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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