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A Clinical Study of Allogeneic Human Dermal Fibroblasts for Remodeling Scar Contractures

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: NCT01564407
Recruitment Status : Terminated (Study Terminated due to lack of Funding)
First Posted : March 27, 2012
Results First Posted : May 12, 2017
Last Update Posted : July 11, 2017
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
J. Peter Rubin, MD, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions Restrictive Scar Contracture
Restrictive Hypertrophic Scar
Burn Scar Contractures
Burn Scar
Intervention Drug: ICX-RHY-013
Enrollment 15
Recruitment Details Multiple approaches for subject recruitment were implemented.The Center for Innovation in Restorative (CIRM) hired a marketing specialist who investigated the use of non-traditional mechanisms within and outside the existing infrastructure including but not limited to social media outlet,use of internal/external physician networks,TV advertising
Pre-assignment Details All of the subjects who were enrolled (signed consent) were randomized to 1 of 4 cohorts.
Arm/Group Title No Injection Vehicle Only Single Admin Drug Day 0 Single Admin Drug Day 28 Admin Drug Day 0 and 28
Hide Arm/Group Description Safety cohort. 4 subjects received empty control. No injection Vehicle only (0.5 ml of solution) Single administration of study drug on day 0 Single administration on Day 28 Single administration day 0 and 28
Period Title: Overall Study
Started 4 5 4 2 0
Completed 4 3 4 1 0
Not Completed 0 2 0 1 0
Reason Not Completed
Lost to Follow-up             0             1             0             0             0
Withdrawal by Subject             0             1             0             0             0
funding lost, study ended             0             0             0             1             0
Arm/Group Title No Injection Vehicle Only Single Admin Day 0 Single Admin Day 28 Admin Day 0 and 28 Total
Hide Arm/Group Description Empty safety control, no injection Vehicle only (0.5 ml of HypoThermosol solution) 5 million cells / cm² , single administration at Day 0 5 million cells/ cm² , single administration at day 28 5 million cells/cm² , single administration at Day 0 , repeat administration of this dose @ day 28 Total of all reporting groups
Overall Number of Baseline Participants 4 5 4 2 0 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 4 participants 2 participants 0 participants 15 participants
<=18 years 0 0 0 0 0
Between 18 and 65 years 4 5 4 2 15
>=65 years 0 0 0 0 0
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 5 participants 4 participants 2 participants 0 participants 15 participants
32.25  (12.3) 41.25  (17.0) 45.75  (14.9) 62  (0) 45.3  (12.4)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 4 participants 2 participants 0 participants 15 participants
Female 4 1 0 0 5
Male 0 4 4 2 10
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 5 participants 4 participants 2 participants 0 participants 15 participants
4 5 4 2 15
1.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description The evaluation of safety of ICX-RHY-013 in the treatment of stable, restrictive hypertrophic scars through assessment of adverse events. The primary objective of the safety (no injection) cohort is to evaluate initial safety of multiple doses through assessment of adverse events. The primary objective of remaining cohorts is to evaluate the ongoing safety of ICX-RHY-013 in post-burn hypertrophic scars that are not planned for excision through assessment of adverse events.
Time Frame Days 0, 7, 14, 28, 56, 84
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title no Injection Vehicle Only Single Admin Drug Day 0 Single Admin Drug Day 28
Hide Arm/Group Description:
Empty control no injection
Vehicle only (0.5 ml of solution)
Single administration of study drug on day 0
Single administration of study drug on day 28
Overall Number of Participants Analyzed 4 3 4 1
Measure Type: Number
Unit of Measure: participants
4 3 4 1
2.Primary Outcome
Title Number of Participants With Serious Adverse Events Reported
Hide Description The evaluation of tolerability of ICX-RHY-013 in the treatment of stable, restrictive hypertrophic scars through regular assessment of adverse events.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Injection Vehicle Only Single Admin Drug Day 0 Single Admin Drug Day 28
Hide Arm/Group Description:
Safety cohort. 4 subjects received empty control. No injection
Vehicle only (0.5 ml of solution)
Single administration of study drug on day 0
Single administration on Day 28
Overall Number of Participants Analyzed 4 3 4 1
Measure Type: Number
Unit of Measure: participants
0 0 0 0
3.Secondary Outcome
Title Percentage of Subjects Worse Hypertrophic Scars
Hide Description The secondary objectives of this study are to evaluate improvement in symptoms of hypertrophic scars.
Time Frame Endpoints assessed at Day 84.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title no Injection Vehicle Only Single Admin Drug Day 0 Single Admin Drug Day 28
Hide Arm/Group Description:
Safety cohort. 4 subjects received empty control. No injection
Vehicle only (0.5 ml of solution)
Single administration of study drug on day 0
Single administration of study drug on day 28
Overall Number of Participants Analyzed 4 3 4 1
Measure Type: Number
Unit of Measure: percentage of paricipants
0 0 0 0
4.Secondary Outcome
Title Vancouver Scar Scale
Hide Description Vancouver scar scale will be evaluated for each cohort. The Vancouver scar scale is the most frequently cited assessment of scar severity used in clinical studies. Pigmentation, vascularity, pliability, and scar height are graded producing a composite score. A score of 0 represents normal skin with higher grades representing greater deformity with a maximum possible rating of 14.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Admin Day 0 Single Admin Day 28 Admin Day 0 and 28 No Injection Vehicle Only
Hide Arm/Group Description:
5 million cells / cm² , single administration at Day 0
5 million cells/ cm² , single administration at day 28
5 million cells/cm² , single administration at Day 0 , repeat administration of this dose @ day 28
Empty safety control, no injection
Vehicle only (0.5 ml of HypoThermosol solution)
Overall Number of Participants Analyzed 4 2 0 4 5
Mean (Standard Deviation)
Unit of Measure: scores on a scale
8  (2) 10  (2.2) 10  (3) 8  (1.3)
5.Secondary Outcome
Title Patient and Observer Scar Assessment Scale (POSAS)
Hide Description POSAS aims to measure scar quality, it is a comprehensive scale designed for the evaluation of all types of scars by professionals and patients. It contains two scales with six items, scored numerically from 0-10, where 0 is normal skin and 10 is the worst scar imaginable. the total scoring range is from 0-120.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Admin Day 0 Single Admin Day 28 Admin Day 0 and 28 No Injection Vehicle Only
Hide Arm/Group Description:
5 million cells / cm² , single administration at Day 0
5 million cells/ cm² , single administration at day 28
5 million cells/cm² , single administration at Day 0 , repeat administration of this dose @ day 28
Safety cohort. 4 subjects received empty control. No injection
Vehicle only (0.5 ml of solution)
Overall Number of Participants Analyzed 4 2 0 4 5
Mean (Standard Deviation)
Unit of Measure: scores on a scale
24.67  (1.53) 34.25  (11.32) 42.13  (8.16) 41.57  (4.32)
6.Secondary Outcome
Title Disability Index-Disability of Arm, Shoulder and Hand
Hide Description The six subjects suffering from upper extremity and cervical scar contractures were evaluated with the Disability of Arm, Shoulder and Hand (DASH) questionnaire. The DASH questionnaire evaluates symptoms and functional status. A lowest score of 0 indicates normal skin and highest score of 100 represents the greatest possible morbidity.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Admin Day 0 Single Admin Day 28 Admin Day 0 and 28 No Injection Vehicle Only
Hide Arm/Group Description:
5 million cells / cm² , single administration at Day 0
5 million cells/ cm² , single administration at day 28
5 million cells/cm² , single administration at Day 0 , repeat administration of this dose @ day 28
Safety cohort. 4 subjects received empty control. No injection
Vehicle only (0.5 ml of solution)
Overall Number of Participants Analyzed 4 2 0 4 5
Mean (Standard Deviation)
Unit of Measure: scores on a scale
6.9  (6) 11.6  (14.1) 75.5  (3.8) 69.2  (12.7)
7.Secondary Outcome
Title Quality of Life Measurement - Satisfaction With Appearance Scale (SWAP)
Hide Description SWAP is a psychological test for personality diagnosis. there are 9 questions evaluated by a score of 7 (most descriptive to the patient) to 0 (not descriptive or irrelevant) for a total scoring range of 0-63.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Admin Day 0 Single Admin Day 28 Admin Day 0 and 28 No Injection Vehicle Only
Hide Arm/Group Description:
5 million cells / cm² , single administration at Day 0
5 million cells/ cm² , single administration at day 28
5 million cells/cm² , single administration at Day 0 , repeat administration of this dose @ day 28
Safety cohort. 4 subjects received empty control. No injection
Vehicle only (0.5 ml of solution)
Overall Number of Participants Analyzed 4 2 0 4 5
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.67  (7.37) 37.75  (14.73) 13.35  (4.12) 23.27  (9.87)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vehicle Only, Single Admin Day 0 Single Admin Day 28 Admin Day 0 and 28 no Injection
Hide Arm/Group Description Adverse events in each cohort included pain, swelling and redness at the site of injection that resolved within 8 hours of treatment Adverse events in each cohort included pain, swelling and redness at the site of injection that resolved within 8 hours of treatment Adverse events in each cohort included pain, swelling and redness at the site of injection that resolved within 8 hours of treatment Adverse events in each cohort included pain, swelling and redness at the site of injection that resolved within 8 hours of treatment Adverse events in each cohort included pain, swelling and redness at the site of injection that resolved within 8 hours of treatment
All-Cause Mortality
Vehicle Only, Single Admin Day 0 Single Admin Day 28 Admin Day 0 and 28 no Injection
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)      0/4 (0.00%)      0/2 (0.00%)      0/0      0/4 (0.00%)    
Hide Serious Adverse Events
Vehicle Only, Single Admin Day 0 Single Admin Day 28 Admin Day 0 and 28 no Injection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5 (0.00%)      0/4 (0.00%)      0/2 (0.00%)      0/0      0/4 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vehicle Only, Single Admin Day 0 Single Admin Day 28 Admin Day 0 and 28 no Injection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/5 (100.00%)      4/4 (100.00%)      2/2 (100.00%)      0/0      0/4 (0.00%)    
Blood and lymphatic system disorders           
Bleeding [1]  1/5 (20.00%)  1 1/4 (25.00%)  1 0/2 (0.00%)  0 0/0  0 0/4 (0.00%)  0
Skin and subcutaneous tissue disorders           
Redness  4/5 (80.00%)  4 3/4 (75.00%)  3 1/2 (50.00%)  1 0/0  0 0/4 (0.00%)  0
Itching  3/5 (60.00%)  3 3/4 (75.00%)  3 2/2 (100.00%)  2 0/0  0 0/4 (0.00%)  0
Bruising  2/5 (40.00%)  2 1/4 (25.00%)  1 1/2 (50.00%)  1 0/0  0 0/4 (0.00%)  0
Swelling  1/5 (20.00%)  1 2/4 (50.00%)  2 1/2 (50.00%)  1 0/0  0 0/4 (0.00%)  0
Warmth  0/5 (0.00%)  0 1/4 (25.00%)  1 1/2 (50.00%)  1 0/0  0 0/4 (0.00%)  0
Pain  3/5 (60.00%)  3 2/4 (50.00%)  2 1/2 (50.00%)  1 0/0  0 0/4 (0.00%)  0
[1]
Bleeding from injection and also biopsy
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: Amy Steele, RN, MSN, CCRC
Organization: University of Pittsburgh
Phone: 412-641-3728
EMail: steeleam@upmc.edu
Layout table for additonal information
Responsible Party: J. Peter Rubin, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01564407    
Other Study ID Numbers: PRO10110342
First Submitted: December 20, 2011
First Posted: March 27, 2012
Results First Submitted: February 18, 2016
Results First Posted: May 12, 2017
Last Update Posted: July 11, 2017