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Effect of Concentrating Endogenous Stromal Cells in the Fat Graft

NCT01564524 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 3

Last updated 2016-10-25

No results posted yet for this study

Summary

Traumatic facial injuries, especially those sustained in military combat, are characterized by destruction of bone and soft tissue. While the bony structures of the face can be reconstructed, it is difficult to return the soft tissue back to its original form. Many times, fat grafting, a common cosmetic and reconstructive procedure, is used in hopes of improving the soft tissue deformity. Fat grafting is a procedure in which a person's own fat is taken from areas throughout the body, usually the thighs or abdomen, with a small liposuction tube. The fat is then transferred into the area that has lost volume or fullness. The fullness of the soft tissue area may decrease over time because the transferred fat can be reabsorbed by the body. Altering the current fat grafting procedure, slightly, could lead to less reabsorption and a lasting fullness of the soft tissue area outcome of the fat graft procedure.

We are conducting this research study to help us improve the surgical treatment of people who have suffered facial soft tissue loss as a result of trauma. The goal of this research study is to see how each person's fat grafts will maintain the fat over time and to measure the quality of life during a 9 month post-surgical follow-up period. The total duration of participation is approximately 11 months.

In this study, we will concentrate the fat in the fat grafting procedure to determine whether this process will maintain the fat over time. The areas treated with enhanced fat grafts will be compared with areas treated with standard of care fat grafts. At least two areas of your face will be treated with fat grafts, (standard of care fat grafts and concentrated fat grafts).

Conditions

  • Facial Injuries
  • Adipose Tissue

Interventions

PROCEDURE

Fat graft surgical procedure

The fat graft surgical procedure will concentrate the adipose stromal cells (ASCs) in the fat graft material. A blunt tip hollow cannula is used to aspirate approximately 200-400cc of fat tissue. The aspirated fat is divided into two portions: one portion will be processed as standard graft material, the other portion will be used in a processing step that concentrates the ASCs. The aspirated fat processed as standard graft material will be divided into small alioquots and centrifuged to separate the aqueous and oil layers, and transferred into 1ml syringes. Standard fat graft material will serve as a control treatment and will be injected into one area of the face. The ASC concentrated graft material will be processed so it first separates the ASCs in a brief collagenase digestion and then resuspends the ASCs in the native fat tissue from which the stromal cells were derived. The ASC concentrated fat will be injected into another region of the face.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • J. Peter Rubin, MD · University of Pittsburgh

Eligibility

Min Age
18 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01564524 on ClinicalTrials.gov