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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Pittsburgh
Sponsor:
Collaborator:
Information provided by (Responsible Party):
J. Peter Rubin, MD, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01633892
First received: June 21, 2012
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Craniofacial Injuries
Procedure: Fat Grafting

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Concentrated Endogenous Autologous Adipose Stromal Cells in Fat Grafts for Craniofacial Trauma

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Persistance of fat graft volume and facial form by enhancing graft quality with a higher concentration of endogenous autologous adipose stromal cells in the grafted tissue monitored over a 9 month period [ Time Frame: 0-9months ] [ Designated as safety issue: No ]
    1. Aesthetic grading scales
    2. 3D photography
    3. High resolution CT scanning with 3D reconstruction.


Secondary Outcome Measures:
  • Measure quality of life in subjects after grafting using validated psychosocial measures. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Correlation of biologic properties of the ASCs with clinical outcomes, and expand and bank cells. [ Time Frame: time of fat grafting to indefinite future date for banked cells ] [ Designated as safety issue: No ]
    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

  • Characterization of adipose stromal cell (ASC) function in each fat graft with and without additional adipose stromal vascular cells in each subject [ Time Frame: 9months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 5
Study Start Date: June 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fat Grafting Procedure: Fat Grafting

Detailed Description:

Craniofacial injuries have serious psychosocial sequele and affect quality of life. Many individuals who suffer significant facial disfigurement from injury experience psychological distress and impairment in functioning not limited to the acute phase of injury, but over a longer term period of treatment, recovery, and adjustment. Until recently, treatment of disfiguring craniofacial injuries has been mostly limited to surgical flap procedures, microsurgical tissue transfer, and implantable prostheses. However, these methods can leave conspicuous scars on the face and the donor site, and in the case of implants can lead to complications associated with foreign materials. Autologous fat grafting with minimally invasive cannulas is a procedure that has been used for decades in common plastic surgery practice for facial aesthetic procedures. This technique is also a promising treatment for soft tissue reconstruction after craniofacial trauma because the graft harvest and injection are minimally invasive. The treatment is performed by using a small liposuction cannula to aspirate fat tissue from the donor site, and then re-injecting the fat into the recipient site with specialized injection cannulas. After harvest, and prior to injection, the fat graft is subjected to a mechanical processing step to separate the aqueous layer and concentrate the adipocytes. This often takes the form of centrifugation or filtering.

The main problem with autologous fat grafting is a variable resorption of the graft volume over time. As much as 30-60% of the graft volume can diminish over time. Many variables may influence the behavior of clinical fat grafts, including harvest site, harvest technique, graft preparation, and injection technique.

Concentrating the already present autologous adipose stromal cells within the fat grafts is not expected to increase subject risk levels beyond the risk levels of the application of fat grafts. We are currently approved for the application of fat grafts with concentrated autologous adipose stromal cells [IRB#10100293]. This proposal uses an increased concentration of adipose stromal cells compared to the above referenced study; no increase of risk to the subject is anticipated. We hypothesize that fat grafting for facial trauma, facilitated by enhancing graft quality with a higher concentration of endogenous autologous vascular adipose stromal cells in the grafted tissue, will enhance the successful restoration of tissue volume and craniofacial form. The use of a higher concentration of autologous adipose stromal cells may lead to lower fat resorption rates that may be observed in the approved IRB study [PRO10100293]. Additionally, we hypothesize that the clinical results using the concentrated autologous stromal vascular cells will be durable and the subject's quality of life scores will be improved compared to subjects who have had fat grafting alone using historical controls.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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,

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01633892

Contacts
Contact: Carroll Lee, BSN 412-864-2587 restore@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Carroll Lee, BSN    412-864-2587    restore@upmc.edu   
Principal Investigator: J. Peter Rubin, MD         
Sub-Investigator: Jeffery A. Gusenoff, MD         
Sub-Investigator: Barton F. Branstetter, MD         
Sub-Investigator: Kacey G. Marra, PhD         
Sub-Investigator: Gretchen L. Haas, PhD         
Sub-Investigator: Diana Mermon,, MS         
Sub-Investigator: Patsy Simon, RN, BS         
Sub-Investigator: Wendy Wakefield, CRNP         
Sub-Investigator: Tashin O Acarturk, MD         
Sub-Investigator: Jenelle Mock, BSN, CCRC         
Sub-Investigator: Jacqueline Bliley, BS         
Sub-Investigator: Elizabeth Radomsky, PhD         
Sub-Investigator: Mara Yerk, BS         
Sub-Investigator: Carroll Lee, BSN         
Sub-Investigator: Ryan Mitchell, MD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: J. Peter Rubin, MD University of Pittsburgh
  More Information

Publications:

Responsible Party: J. Peter Rubin, MD, Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01633892     History of Changes
Other Study ID Numbers: PRO12010078
Study First Received: June 21, 2012
Last Updated: March 19, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Pittsburgh:
Craniomaxillofacial (CMF)
Battle-injured (BI)
Facial Trauma
Fat Grafts
Autogenous Fat Transfers (AFT)
Wounded warriors
Adipose Tissue

ClinicalTrials.gov processed this record on November 25, 2014