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OpenTrials
Completed

NCT Number: NCT02320812

Safety of a Single, Intravitreal Injection of Human Retinal Progenitor Cells (jCell) in Retinitis Pigmentosa

This study evaluates the safety and potential activity of a single dose of live human retinal progenitor cells (jCell) administered to adults with retinitis pigmentosa. Four different dose levels of cells will be assessed in each of two groups of patients.

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Key information

Conditions

Retinitis Pigmentosa (RP) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Retinal Degeneration Retinal Diseases Retinal Dystrophies Retinitis Pigmentosa

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Gavin Herbert Eye Institute, Univ California Irvine, Irvine, California, United States

Loading trial locations.

About this study

The primary purpose of this study is to test the safety and tolerability of the administration of a single dose of jCell to adults with retinitis pigmentosa.

The goal of jCell therapy is to preserve vision by intervening in the disease at a time when host photoreceptors can be protected and potentially reactivated.

Human allogeneic retinal progenitor cells will be injected into adults with advanced RP to see if the procedure is safe, if the cells survive, and whether they have any impact on the visual status of the patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

human retinal progenitor cells

Biological

single intravitreal injection of 0.5 - 3.0 million human retinal progenitor cells (hRPC)

Other names: jCell

Primary outcomes

  1. Number of Subjects With Adverse Events as a Measure of Safety and Tolerability

    Time frame: 12 months

    proportion of subjects with treatment emergent adverse events (TEAE), related TEAE and severe TEAE

Secondary outcomes

  1. Change in Mean Best Corrected Visual Acuity (BCVA)

    Time frame: 12 months

    change in mean best corrected visual acuity in test eye versus untreated eye; BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. Change between baseline and month 12 is reported.

Sponsors and collaborators

Lead sponsor

jCyte, Inc

Industry

Collaborators

  • California Institute for Regenerative Medicine (CIRM)

Registry information

Official study title

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)

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 19, 2014
Registry last updated
Mar 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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