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Trial record 1 of 29 for:    Scar Contractures
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A Clinical Study of Allogeneic Human Dermal Fibroblasts for Remodeling Scar Contractures

This study has been terminated.
(Study Terminated due to lack of Funding)
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
J. Peter Rubin, MD, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01564407
First received: December 20, 2011
Last updated: May 10, 2017
Last verified: May 2017
Results First Received: February 18, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Basic Science
Conditions: Restrictive Scar Contracture
Restrictive Hypertrophic Scar
Burn Scar Contractures
Burn Scar
Intervention: Drug: ICX‐RHY‐013

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All of the subjects who were enrolled (signed consent) were randomized to 1 of 4 cohorts.

Reporting Groups
  Description
No Injection Safety cohort. 4 subjects received empty control. No injection
Vehicle Only Vehicle only (0.5 ml of solution)
Single Admin Drug Day 0 Single administration of study drug on day 0
Single Admin Drug Day 28 Single administration on Day 28
Admin Drug Day 0 and 28 Single administration day 0 and 28

Participant Flow:   Overall Study
    No Injection   Vehicle Only   Single Admin Drug Day 0   Single Admin Drug Day 28   Admin Drug Day 0 and 28
STARTED   4   5   4   2   0 
COMPLETED   4   3   4   1   0 
NOT COMPLETED   0   2   0   1   0 
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 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
No Injection Empty safety control, no injection
Vehicle Only Vehicle only (0.5 ml of HypoThermosol solution)
Single Admin Day 0 5 million cells / cm² , single administration at Day 0
Single Admin Day 28 5 million cells/ cm² , single administration at day 28
Admin Day 0 and 28 5 million cells/cm² , single administration at Day 0 , repeat administration of this dose @ day 28
Total Total of all reporting groups

Baseline Measures
   No Injection   Vehicle Only   Single Admin Day 0   Single Admin Day 28   Admin Day 0 and 28   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   5   4   2   0   15 
Age, Customized 
[Units: 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 
[Units: Years]
Mean (Standard Deviation)
 32.25  (12.3)   41.25  (17.0)   45.75  (14.9)   62  (0)      45.3  (12.4) 
Sex/Gender, Customized 
[Units: Participants]
           
Female   4   1   0   0      5 
Male   0   4   4   2      10 
Region of Enrollment 
[Units: Participants]
           
United States   4   5   4   2      15 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Adverse Events   [ Time Frame: Days 0, 7, 14, 28, 56, 84 ]

2.  Primary:   Number of Participants With Serious Adverse Events Reported   [ Time Frame: 12 weeks ]

3.  Secondary:   Percentage of Subjects Worse Hypertrophic Scars   [ Time Frame: Endpoints assessed at Day 84. ]

4.  Secondary:   Vancouver Scar Scale   [ Time Frame: 12 weeks ]

5.  Secondary:   Patient and Observer Scar Assessment Scale (POSAS)   [ Time Frame: 12 weeks ]

6.  Secondary:   Disability Index-Disability of Arm, Shoulder and Hand   [ Time Frame: 12 weeks ]

7.  Secondary:   Quality of Life Measurement - Satisfaction With Appearance Scale (SWAP)   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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:  
Name/Title: Amy Steele, RN, MSN, CCRC
Organization: University of Pittsburgh
phone: 412-641-3728
e-mail: steeleam@upmc.edu



Responsible Party: J. Peter Rubin, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01564407     History of Changes
Other Study ID Numbers: PRO10110342
Study First Received: December 20, 2011
Results First Received: February 18, 2016
Last Updated: May 10, 2017