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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-07-19

Brief Summary

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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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Detailed Description

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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.

Conditions

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Retinitis Pigmentosa (RP)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treated subjects

human retinal progenitor cells

Group Type EXPERIMENTAL

human retinal progenitor cells

Intervention Type BIOLOGICAL

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

Interventions

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human retinal progenitor cells

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

Intervention Type BIOLOGICAL

Other Intervention Names

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jCell

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No