Adipose Tissue Clinical Trial
Official title:
Structural Fat Grafting for Craniofacial Trauma: Effect of Concentrating Endogenous Stromal Cells in the Fat Graft
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).
Status | Terminated |
Enrollment | 3 |
Est. completion date | August 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 110 Years |
Eligibility |
Inclusion Criteria: 1. Aged 18 years or older and able to provide informed consent 2. Have suffered injury resulting in craniofacial volume defects which could be treated with a graft volume of between 3 and 100 cc of lipoaspirate 3. Be at least 3 months post-injury or post-surgery (from trauma procedures) so that acute edema is resolved 4. Volume defects are covered by intact skin and do not communicate with oral cavity or sinuses 5. The three dimensional geometry of the volume defects would allow for treatment with lipoaspirate injection so that at least two distinct treated areas could be discerned on gross examination and radiographically (e.g. treated regions are on opposite sides of the face, on lower face versus upper face, or separated by a bony landmark such as zygoma. This would include the ability to treat an uninjured regions with fat grafts in order to obtain symmetry or balance. 6. Willing and able to comply with follow up examinations, including radiographic studies Exclusion Criteria: 1. Age less than 18 years 2. Inability to provide informed consent 3. Craniofacial defects intended for treatment have open wounds or communicate with oral cavity or sinus (note: presence of such a defect in the setting of another defect(s) that meets treatment criteria will not exclude the patient from participating). 4. Active infection anywhere in the body 5. Diagnosed with cancer within the last 12 months and /or presently receiving chemotherapy or radiation treatment 6. Known coagulopathy 7. Systemic disease that would render the fat harvest and injection procedure, along with associated anesthesia, unsafe to the patient. 8. Pregnancy 9. Diagnosis of Schizophrenia or Bipolar Disorder |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | United States Department of Defense |
United States,
Yoshimura K, Sato K, Aoi N, Kurita M, Hirohi T, Harii K. Cell-assisted lipotransfer for cosmetic breast augmentation: supportive use of adipose-derived stem/stromal cells. Aesthetic Plast Surg. 2008 Jan;32(1):48-55; discussion 56-7. Epub 2007 Sep 1. — View Citation
Zhu M, Zhou Z, Chen Y, Schreiber R, Ransom JT, Fraser JK, Hedrick MH, Pinkernell K, Kuo HC. Supplementation of fat grafts with adipose-derived regenerative cells improves long-term graft retention. Ann Plast Surg. 2010 Feb;64(2):222-8. doi: 10.1097/SAP.0b013e31819ae05c. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fat grafting for facial trauma, facilitated by enhancing graft quality with a higher concentration of endogenous autologous adipose stromal cells in the grafted tissue, will enable successful restoration of tissue volume and craniofacial form. | Facial appearance and persistence of graft volume will be assessed using aesthetic grading scales, state of the art 3D photography, and high resolution CT scanning with 3D reconstruction. Subjects will be followed for 9 months after graft procedure to define long term outcomes. | Will take at months 9 after the fat grafting procedure | No |
Secondary | Measure quality of life in subjects after grafting using validated psychosocial measures. | A comprehensive battery of tests for evaluation of quality of life has been assembled for this study. It is important to properly determine the impact of the surgical changes and the investigators have selected Psychosocial assessment instruments to evaluate four domains: a) Satisfaction with appearance/surgical outcomes; b) Satisfaction with Medical/Health Services; c) Social Functioning, Distress, Avoidance; d) Quality of Life and General Functioning Outcomes. | 9 months | No |
Secondary | Cell assessment will include adipose ASC yield, cell proliferation and characterization, capacity for adipogenic differentiation, interactions with biomaterial scaffolds that may be used in future therapies, and analysis by flow cytometry. | Cell assessment will include adipose ASC yield, cell proliferation and characterization, capacity for adipogenic differentiation, interactions with biomaterial scaffolds that may be used in future therapies, and analysis by flow cytometry. | At the end of the 4 week observation period after entry into the study, at which time the intervention will occur and the cells will be analyzed. | No |
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