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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04604899
Recruitment Status : Active, not recruiting
First Posted : October 27, 2020
Last Update Posted : May 7, 2021
Sponsor:
Collaborator:
California Institute for Regenerative Medicine (CIRM)
Information provided by (Responsible Party):
jCyte, Inc

Tracking Information
First Submitted Date  ICMJE October 16, 2020
First Posted Date  ICMJE October 27, 2020
Last Update Posted Date May 7, 2021
Actual Study Start Date  ICMJE December 1, 2020
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2020)
Safety of intravitreal injection of hRPC [ Time Frame: 12 months ]
Assessed by proportion of subjects with treatment emergent adverse events
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2020)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of Repeat Intravitreal Injection of Human Retinal Progenitor Cells (jCell) in Adult Subjects With Retinitis Pigmentosa
Official Title  ICMJE A Phase 2 Study of the Safety of Repeat Intravitreal Injection of Human Retinal Progenitor Cells (jCell) in Adult Subjects With Retinitis Pigmentosa (RP)
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.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Retinitis Pigmentosa
Intervention  ICMJE Biological: human retinal progenitor cells
single intravitreal injection of 6.0 million human retinal progenitor cells (hRPC)
Other Name: jCell
Study Arms  ICMJE Experimental: Retreated subjects
Subjects receiving human retinal progenitor cells (jCell) who have previously received jCell is a jCyte study.
Intervention: Biological: human retinal progenitor cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 21, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Willing to give written informed consent, able to make the required study visits and follow study protocol instructions.
  2. 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.
  3. 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
  4. 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.

Exclusion Criteria:

  1. 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.
  2. 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
  3. Allergy to penicillin or streptomycin.
  4. Adverse reaction to DMSO.
  5. Unable or unwilling to undergo pupil dilation, topical anesthesia or any protocol-required procedure.
  6. Women who are nursing or who are planning to nurse during the 12 months that would follow study treatment.
  7. Any circumstance that in the opinion of the investigator, would interfere with participation in, or compliance with the study protocol
  8. 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.
  9. Cataract surgery within three months prior to treatment or anticipated to need cataract surgery within a year of treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04604899
Other Study ID Numbers  ICMJE JC02-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party jCyte, Inc
Study Sponsor  ICMJE jCyte, Inc
Collaborators  ICMJE California Institute for Regenerative Medicine (CIRM)
Investigators  ICMJE
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
PRS Account jCyte, Inc
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP