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Use of Concentrated Endogenous Autologous Adipose Stromal Cells in Fat Grafts for Craniofacial Trauma (ARM5)

This study has been terminated.
(funding ended)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01633892
First Posted: July 4, 2012
Last Update Posted: August 3, 2017
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.
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
J. Peter Rubin, MD, University of Pittsburgh
Results First Submitted: May 12, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Craniofacial Injuries
Intervention: Procedure: Fat Grafting

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Fat Grafting Fat Grafting procedure designed to deliver an autologous fat graft admixed with autologous stromal vascular fraction (SVF) at a high cell dose.

Participant Flow:   Overall Study
    Fat Grafting
STARTED   5 
COMPLETED   5 
NOT COMPLETED   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
Fat Grafting Fat Grafting procedure designed to deliver an autologous fat graft admixed with autologous stromal vascular fraction (SVF) at a high cell dose.

Baseline Measures
   Fat Grafting 
Overall Participants Analyzed 
[Units: Participants]
 5 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      5 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      1  20.0% 
Male      4  80.0% 
Region of Enrollment 
[Units: Participants]
 
United States   5 
Skin Volume (cc) 
[Units: Cc]
Median (Standard Deviation)
 5  (0) 
Skin Thickness (mm) 
[Units: Mm]
Median (Standard Deviation)
 5  (0) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Average Fat Graft Volume Facial Form From Baseline up to 9 Months   [ Time Frame: 0, 1, 3, and 9 months ]

2.  Primary:   Average Tissue Thickness From Baseline up to 9 Months   [ Time Frame: 0, 1, 3, and 9 months ]

3.  Secondary:   Measure Quality of Life in Subjects After Grafting Using Validated Psychosocial Measures.   [ Time Frame: 9 months ]

4.  Secondary:   Composition of SVF   [ Time Frame: time of fat grafting, up to 12 hours post-baseline ]

5.  Secondary:   Characterization of Adipose Stromal Cell (ASC) Function   [ Time Frame: time of surgery, up to 12 hours post-baseline ]


  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
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  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: J. Peter Rubin
Organization: University of Pittsburgh
phone: 412-624-9703
e-mail: rubipj@upmc.edu


Publications:


Responsible Party: J. Peter Rubin, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01633892     History of Changes
Other Study ID Numbers: PRO12010078
First Submitted: June 21, 2012
First Posted: July 4, 2012
Results First Submitted: May 12, 2016
Results First Posted: August 3, 2017
Last Update Posted: August 3, 2017