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

NCT04604899 | Completed Phase 2 Results FDA Drug

• 1 other identifier: JC02-2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Retinitis Pigmentosa

Outcome Measures

Primary Outcomes (1)

• Safety of Intravitreal Injection of hRPC

  Assessed by percentage of subjects with treatment emergent adverse events

  12 months

Secondary Outcomes (4)

• Best Corrected Visual Acuity (BCVA)

  12 months

• Kinetic Visual Field Area

  12 months

• Contrast Sensitivity (Peak)

  12 months

• Low Luminance Mobility Test (LLMT)

  12 months

Study Arms (1)

Retreated subjects

EXPERIMENTAL

Subjects receiving human retinal progenitor cells (jCell) who have previously received jCell is a jCyte study.

Biological: human retinal progenitor cells

Interventions

human retinal progenitor cells BIOLOGICAL

single intravitreal injection of 6.0 million human retinal progenitor cells (hRPC)

Also known as: jCell

Retreated subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• jCyte, Inc: lead
• California Institute for Regenerative Medicine (CIRM): collaborator

Study Sites (3)

Gavin Herbert Eye Inst, Univ Cal Irvine

Irvine, California, 92697, United States

Location

Retina-Vitreous Associates Medical Group

Los Angeles, California, 90074, United States

Location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Chief Strategy Officer
• Organization: jCyte, Inc.

media@jcyte.com

9492430687

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: October 27, 2020
• Study Start: December 1, 2020
• Primary Completion: March 22, 2022
• Study Completion: March 22, 2022
• Last Updated: July 16, 2024
• Results First Posted: September 26, 2023

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)