Trial record 2 of 15 for:    Open Studies | "Facial Injuries"

Effect of Concentrating Endogenous Stromal Cells in the Fat Graft Using TGI Device (AFIRM-TGI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
J. Peter Rubin, MD, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01924364
First received: December 21, 2012
Last updated: August 14, 2013
Last verified: August 2013
  Purpose

The overall purpose of this research is to evaluate the physical changes that occur over time after fat grafting for craniofacial trauma. This protocol is similar to an existing study (IRB# PRO0906101) presently conducted at the University of Pittsburgh by the same research team which utilizes fat grafts. The preparation of the fat graft material in each clinical trial is processed differently evaluating the effects of graft resorption after treatment.


Condition Intervention Phase
Facial Injuries
Tissue Injury
Device: Tissue Genesis Cell Isolation System™ (CIS)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Structural Fat Grafting for Craniofacial Trauma: Effect of Concentrating Endogenous Stromal Cells in the Fat Graft Using the Tissue Genesis Cell Isolation System™ (CIS) Device

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Assess change of soft tissue volume and contour following fat graft procedure [ Time Frame: Surgical visit, PO Study visits month 1 (V1), month 3 (V2), month 6 (V3), month 9 (V4), month 12 (V5), and year 2 (V6) ] [ Designated as safety issue: No ]
    Facial appearance and persistence of treatment effect will be assessed using aesthetic grading scales, state of the art 3D photography, and high resolution CT scanning with 3D reconstruction. Patients will be followed for 24 months after treatment to define long term outcomes. Primary outcome is an assessment of soft tissue volume and contour, as assessed by high resolution radiographic imaging with 3-d renderings comparisons, 3-dimensional photography, and clinical examination.


Secondary Outcome Measures:
  • Assess potential change in the biologic properties of the cells within the fat graft and correlate with clinical outcomes. [ Time Frame: Surgical visit, PO Study visits month 1 (V1), month 3 (V2), month 6 (V3), month 9 (V4), month 12 (V5), and year 2 (V6) ] [ Designated as safety issue: No ]
    This will include adipose stem cell yield per volume of fat tissue, cell proliferation, capacity for adipogenic differentiation, lipolysis, and cell sub-population analysis by multiparameter flow cytometry. Results of these assays will be correlated with graft volume retention to search for predictors of good clinical outcome that are related to variation on adipose biology between subjects.


Other Outcome Measures:
  • Quality of life measures. [ Time Frame: Before Surgery: Pre-graft study visits 1 and 2. After Surgery: month 1 (V1), month 3 (V2), month 6 (V3), month 9 (V4), month 12 (V5), and year 2 (V6) ] [ Designated as safety issue: No ]
    Measure quality of life in patients before and after autologous fat grafting using validated psychosocial measures.


Estimated Enrollment: 5
Study Start Date: June 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fat grafting Device: Tissue Genesis Cell Isolation System™ (CIS)
In this study, we will concentrate the adipose stromal cells (ASCs) in the fat graft material to assess whether this modification will increase fat graft retention over time. The concentrated fat to be injected into the subject from the fat grafting procedure will be processed by the Tissue Genesis Cell Isolation System™ (CIS) device. The volume retention in areas treated with ASC concentrated fat grafts will be compared with regions treated with standard fat grafts in the same patient. Additionally, data from our current study assessing volume retention after fat grafting for facial deformities (IRB # PRO09060101) will be used for comparison.

Detailed Description:

The primary objective of the proposed clinical investigation of the Tissue Genesis Cell Isolation System™ (CIS) device constitutes a feasibility study directed at an initial evaluation of the device in a certain clinical population, namely subjects undergoing craniofacial fat grafting.

  1. Treat disfiguring craniofacial injuries in 5 subjects with fat grafting enhanced with adipose SVF via TGI 1000 isolation methods to improve form with a high level of precision. Facial appearance and persistence of treatment effect will be assessed using aesthetic grading scales, state of the art 3D photography, and high resolution CT scanning with 3D reconstruction. Patients will be followed for 24 months after treatment to define long term outcomes.
  2. Assess biologic properties of the cells within the fat graft and correlate with clinical outcomes. This will include adipose stem cell yield per volume of fat tissue, cell proliferation, capacity for adipogenic differentiation, lipolysis, and cell sub-population analysis by multiparameter flow cytometry. Results of these assays will be correlated with graft volume retention to search for predictors of good clinical outcome that are related to variation on adipose biology between subjects.
  3. Measure quality of life in patients before and after autologous fat grafting using validated psychosocial measures.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Subjects who are male or female, military or civilian, 18 years of age 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 uninjured regions with fat grafts in order to obtain symmetry or balance.

    6. Subjects who are, in the opinion of the Investigator, able to understand the study, comply with the study design and are willing to return to the clinic for all the research required follow-up visits

Exclusion Criteria:

  • 1. 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).

    2. Active infection anywhere in the body

    3. Diagnosis of cancer within last 12 months and /or actively receiving chemotherapy or radiation treatment

    4. Subjects with known idiopathic or drug-associated coagulopathy assessed by screening history and physical examination.

    5. Subjects who have, as determined by the investigator a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study (i.e. Type 1 and Type 2 diabetic patients) or any condition within the last 14 days requiring hospitalization or surgical intervention.

    6. Subjects who are pregnant, lactating, and women of child-bearing potential who are not abstinent or practicing an acceptable means of contraception, as determined by the Investigator, for the duration of the treatment phase

    7. Subjects with known alcohol or narcotic drug dependency

    8. Subjects with a history of abnormal blood biochemistry or any other abnormal laboratory findings, as defined by the normal value range within the UPMC Laboratory's value references and whose values are considered as determined by the investigator to be clinically significant, would render the subject inappropriate for the surgical procedures (i.e. CBC with Differential, platelets, comprehensive metabolic panel to include electrolytes, bun/creatinine, liver function test and coagulation tests). Reference to UPMC Laboratory normal value document (Attachment # 18)

    9. Subjects with a life expectancy of <9 months, terminal conditions or factors making follow-up difficult (e.g. no fixed address, telephone etc)

    10. Subjects with a known allergy to collagenase, an ingredient used by the TGI CIS to process the SVF product.

    11. Subjects with an Axis II to diagnosis DSM-IV (e.g., Schizophrenia, Bipolar Disorder). Subjects who are found to be stable on medication and receive psychiatric clearance could be eligible for study participation per the Physician's discretion.

  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: NCT01924364

Contacts
Contact: CIRM 412-864-2587 Restore@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: CIRM    412-864-2587    Restore@upmc.edu   
Principal Investigator: J. Peter Rubin, MD         
Sub-Investigator: Megan A Hendricks, BA, RN         
Sub-Investigator: Patsy Simon, RN, BS, CCRC         
Sub-Investigator: Peter Adams, BS         
Sub-Investigator: Paul Afrooz, MD         
Sub-Investigator: Jacqueline Bliley, MS         
Sub-Investigator: Barton Branstetter, MD         
Sub-Investigator: Spencer Brown, PhD         
Sub-Investigator: Sydney Coleman, MD         
Sub-Investigator: Vera Donnenberg, PhD         
Sub-Investigator: Albert Donnenberg, PhD         
Sub-Investigator: Jeffrey Gusenoff, MD         
Sub-Investigator: Gretchen Haas, PhD         
Sub-Investigator: Kacey Marra, PhD         
Sub-Investigator: Jenelle Mock, BSN, RN         
Sub-Investigator: Wendy Wakefield, CRNP         
Sub-Investigator: Diana Mermon, MS         
Sub-Investigator: Khalid Almutairi, 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: NCT01924364     History of Changes
Other Study ID Numbers: PRO12030255
Study First Received: December 21, 2012
Last Updated: August 14, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Facial Injuries
Wounds and Injuries
Craniocerebral Trauma

ClinicalTrials.gov processed this record on August 28, 2014