Effect of Concentrating Endogenous Stromal Cells in the Fat Graft

NCT01564524 | Terminated DMC

• 1 other identifier: PRO10100293
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Craniomaxillofacial (CMF) Battle-injured (BI); Facial Trauma; Fat Grafts; Autogenous Fat Transfers (AFT); Wounded warriors

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Measure quality of life in subjects after grafting using validated psychosocial measures.

  9 months

• 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.

Interventions

Fat graft surgical procedure 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.

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Civilian or military

You may qualify if:

• Aged 18 years or older and able to provide informed consent
• Have suffered injury resulting in craniofacial volume defects which could be treated with a graft volume of between 3 and 100 cc of lipoaspirate
• Be at least 3 months post-injury or post-surgery (from trauma procedures) so that acute edema is resolved
• Volume defects are covered by intact skin and do not communicate with oral cavity or sinuses
• 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.
• Willing and able to comply with follow up examinations, including radiographic studies

You may not qualify if:

• Age less than 18 years
• Inability to provide informed consent
• 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).
• Active infection anywhere in the body
• Diagnosed with cancer within the last 12 months and /or presently receiving chemotherapy or radiation treatment
• Known coagulopathy
• Systemic disease that would render the fat harvest and injection procedure, along with associated anesthesia, unsafe to the patient.
• Pregnancy
• Diagnosis of Schizophrenia or Bipolar Disorder

Sponsors & Collaborators

• University of Pittsburgh: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

• 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. doi: 10.1007/s00266-007-9019-4. Epub 2007 Sep 1.

  PMID: 17763894 BACKGROUND

• 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.

  PMID: 20098110 BACKGROUND

MeSH Terms

Conditions

Facial Injuries

Condition Hierarchy (Ancestors)

Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Study Officials

• J. Peter Rubin, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 21, 2012
• First Posted: March 27, 2012
• Study Start: April 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: October 25, 2016

Record last verified: 2016-10

Locations

US (1)