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Stem Cell Therapy
Safety of Repeat Intravitreal Injection of Human Retinal Progenitor Cells (jCell) in Adult Subjects With Retinitis Pigmentosa
Phase 2
Waitlist Available
Led By Mitul Mehta, MD
Research Sponsored by jCyte, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the safety of injecting special retinal cells into adults with retinitis pigmentosa. The goal is to see if a second injection is safe and effective. The special cells can grow into new retinal cells, which may help improve or maintain vision.
Eligible Conditions
- Retinitis Pigmentosa
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety of Intravitreal Injection of hRPC
Secondary study objectives
Best Corrected Visual Acuity (BCVA)
Contrast Sensitivity (Peak)
Kinetic Visual Field Area
+1 moreSide effects data
From 2020 Phase 2 trial • 84 Patients • NCT0307373317%
Conjunctival hemorrhage
10%
Visual acuity reduced
7%
Influenza
7%
Localised infection
3%
Cystoid macular edema
3%
Sinusitis
3%
Intraocular pressure increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sham Treated Control
Test (jCell Injection) Dose Level 1
Test (jCell Injection) Dose Level 2
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Retreated subjectsExperimental Treatment1 Intervention
Subjects receiving human retinal progenitor cells (jCell) who have previously received jCell is a jCyte study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
human retinal progenitor cells
2015
Completed Phase 2
~150
Find a Location
Who is running the clinical trial?
California Institute for Regenerative Medicine (CIRM)OTHER
69 Previous Clinical Trials
3,328 Total Patients Enrolled
3 Trials studying Retinitis Pigmentosa
128 Patients Enrolled for Retinitis Pigmentosa
jCyte, IncLead Sponsor
2 Previous Clinical Trials
112 Total Patients Enrolled
2 Trials studying Retinitis Pigmentosa
112 Patients Enrolled for Retinitis Pigmentosa
Mitul Mehta, MDPrincipal InvestigatorUniversity of California, Irvine/Gavin Herbert Eye Institute
2 Previous Clinical Trials
104 Total Patients Enrolled
1 Trials studying Retinitis Pigmentosa
84 Patients Enrolled for Retinitis Pigmentosa
David Liao, MDPrincipal InvestigatorRetina-Vitreous Associates Medical Group, Los Angeles CA
1 Previous Clinical Trials
84 Total Patients Enrolled
1 Trials studying Retinitis Pigmentosa
84 Patients Enrolled for Retinitis Pigmentosa
Anthony Jospeh, MDPrincipal InvestigatorOphthalmic Consultants of Boston