Safety of a Single, Intravitreal Injection of Human Retinal Progenitor Cells (jCell) in 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: NCT02320812|
Recruitment Status : Completed
First Posted : December 19, 2014
Results First Posted : March 5, 2019
Last Update Posted : March 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Retinitis Pigmentosa (RP)||Biological: human retinal progenitor cells||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official 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)|
|Study Start Date :||June 2015|
|Actual Primary Completion Date :||July 19, 2017|
|Actual Study Completion Date :||July 19, 2017|
Experimental: Treated subjects
human retinal progenitor cells
Biological: human retinal progenitor cells
single intravitreal injection of 0.5 - 3.0 million human retinal progenitor cells (hRPC)
Other Name: jCell
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02320812
|United States, California|
|The Gavin Herbert Eye Institute, Univ California Irvine|
|Irvine, California, United States|
|Retina-Vitreous Associates Medical Group|
|Los Angeles, California, United States, 90074|
|Principal Investigator:||Baruch Kuppermann, MD||Gavin Herbert Eye Institute, UCI, Irvine, CA|