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

NCT01633892 | Terminated Results DMC

• 1 other identifier: PRO12010078
• Study Type: interventional
• Target: 5
• 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. The investigators 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 11-12 months. In this study, the investigators 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). This study is the second of two clinical studies at the University of Pittsburgh using each person's fat graft with concentration of fat cells in the graft to observe if there is less fat resorption compared to using fat grafts alone. Each study is using a different concentration of fat in the fat graft compared to the first clinical study.

Conditions

Craniofacial Injuries

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Average Fat Graft Volume Facial Form From Baseline up to 9 Months

  High resolution CT scanning with 3D reconstruction at 0, 1, 3, and 9 months

  0, 1, 3, and 9 months

• Average Tissue Thickness From Baseline up to 9 Months

  High resolution CT scanning with 3D reconstruction at 0, 1, 3, and 9 months

  0, 1, 3, and 9 months

Secondary Outcomes (3)

• Measure Quality of Life in Subjects After Grafting Using Validated Psychosocial Measures.

  9 months

• Composition of SVF

  time of fat grafting, up to 12 hours post-baseline

• Characterization of Adipose Stromal Cell (ASC) Function

  time of surgery, up to 12 hours post-baseline

Study Arms (1)

Fat Grafting

EXPERIMENTAL

Procedure: Fat Grafting

Interventions

Fat Grafting PROCEDURE

Fat Grafting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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,

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 (7)

• 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

• Masuda T, Furue M, Matsuda T. Novel strategy for soft tissue augmentation based on transplantation of fragmented omentum and preadipocytes. Tissue Eng. 2004 Nov-Dec;10(11-12):1672-83. doi: 10.1089/ten.2004.10.1672.

  PMID: 15684676 BACKGROUND

• Matsumoto D, Sato K, Gonda K, Takaki Y, Shigeura T, Sato T, Aiba-Kojima E, Iizuka F, Inoue K, Suga H, Yoshimura K. Cell-assisted lipotransfer: supportive use of human adipose-derived cells for soft tissue augmentation with lipoinjection. Tissue Eng. 2006 Dec;12(12):3375-82. doi: 10.1089/ten.2006.12.3375.

  PMID: 17518674 BACKGROUND

• Moseley TA, Zhu M, Hedrick MH. Adipose-derived stem and progenitor cells as fillers in plastic and reconstructive surgery. Plast Reconstr Surg. 2006 Sep;118(3 Suppl):121S-128S. doi: 10.1097/01.prs.0000234609.74811.2e.

  PMID: 16936551 BACKGROUND

• Lu F, Li J, Gao J, Ogawa R, Ou C, Yang B, Fu B. Improvement of the survival of human autologous fat transplantation by using VEGF-transfected adipose-derived stem cells. Plast Reconstr Surg. 2009 Nov;124(5):1437-1446. doi: 10.1097/PRS.0b013e3181babbb6.

  PMID: 20009828 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

• Yoshimura K, Asano Y, Aoi N, Kurita M, Oshima Y, Sato K, Inoue K, Suga H, Eto H, Kato H, Harii K. Progenitor-enriched adipose tissue transplantation as rescue for breast implant complications. Breast J. 2010 Mar-Apr;16(2):169-75. doi: 10.1111/j.1524-4741.2009.00873.x. Epub 2009 Nov 12.

  PMID: 19912236 BACKGROUND

Results Point of Contact

• Title: J. Peter Rubin
• Organization: University of Pittsburgh

rubipj@upmc.edu

412-624-9703

Study Officials

• J. Peter Rubin, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 21, 2012
• First Posted: July 4, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 3, 2017
• Results First Posted: August 3, 2017

Record last verified: 2017-04

Locations

US (1)