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

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ClinicalTrials.gov Identifier: NCT02320812
Recruitment Status : Completed
First Posted : December 19, 2014
Results First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Collaborator:
California Institute for Regenerative Medicine (CIRM)
Information provided by (Responsible Party):
jCyte, Inc

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Retinitis Pigmentosa (RP)
Intervention Biological: human retinal progenitor cells
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treated Subjects
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human retinal progenitor cells

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

Period Title: Overall Study
Started 28
Completed 28
Not Completed 0
Arm/Group Title Treated Subjects
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human retinal progenitor cells

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

Overall Number of Baseline Participants 28
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[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants
49.2  (14.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
17
  60.7%
Male
11
  39.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Hispanic or Latino
7
  25.0%
Not Hispanic or Latino
21
  75.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
American Indian or Alaska Native
0
   0.0%
Asian
4
  14.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
24
  85.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants
28
1.Primary Outcome
Title Number of Subjects With Adverse Events as a Measure of Safety and Tolerability
Hide Description proportion of subjects with treatment emergent adverse events (TEAE), related TEAE and severe TEAE
Time Frame 12 months
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Hide Analysis Population Description
all treated subjects
Arm/Group Title Treated Subjects
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human retinal progenitor cells

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

Overall Number of Participants Analyzed 28
Measure Type: Count of Participants
Unit of Measure: Participants
Subjects with TEAE
25
  89.3%
Subjects with related TEAE
21
  75.0%
Subjects with grade 3 TEAE
1
   3.6%
2.Secondary Outcome
Title Change in Mean Best Corrected Visual Acuity (BCVA)
Hide Description 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.
Time Frame 12 months
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Hide Analysis Population Description
all treated subjects
Arm/Group Title 0.5 Million Cells Cohort 1.0 Million Cells Cohort 2.0 Million Cells Cohort 3.0 Million Cells Cohort
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subjects who received 0.5 million human retinal progenitor cells (hRPC)
subjects who received 1.0 million hRPC
subjects who received 2.0 million hRPC
subjects who received 3.0 million hRPC
Overall Number of Participants Analyzed 8 8 6 6
Mean (Full Range)
Unit of Measure: number of letters read correctly
1.4
(-3 to 11)
1.0
(-3 to 11)
4.8
(0 to 8)
9.0
(0 to 12)
Time Frame one year following single intravitreal injection of hRPC
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treated Subjects
Hide Arm/Group Description

human retinal progenitor cells

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

All-Cause Mortality
Treated Subjects
Affected / at Risk (%)
Total   0/28 (0.00%)    
Hide Serious Adverse Events
Treated Subjects
Affected / at Risk (%) # Events
Total   1/28 (3.57%)    
Musculoskeletal and connective tissue disorders   
migratory pain  1 [1]  1/28 (3.57%)  1
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
[1]
Grade 2
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treated Subjects
Affected / at Risk (%) # Events
Total   20/28 (71.43%)    
Eye disorders   
anterior chamber flare  1  5/28 (17.86%)  5
conjunctival hemorrhage  1  10/28 (35.71%)  10
eye pain  1  5/28 (17.86%)  5
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Terry O'Neal, Chief Operating Officer
Organization: jCyte, Inc
Phone: 949-243-0688
EMail: terry.oneal@jcyte.com
Layout table for additonal information
Responsible Party: jCyte, Inc
ClinicalTrials.gov Identifier: NCT02320812    
Other Study ID Numbers: JC-01
First Submitted: December 16, 2014
First Posted: December 19, 2014
Results First Submitted: August 7, 2018
Results First Posted: March 5, 2019
Last Update Posted: March 5, 2019