Clinical Trial: Effect of Concentrating Endogenous Stromal Cells in the Fat Graft Using TGI Device

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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.

Sponsor: University of Pittsburgh

Current Primary Outcome: 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) ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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) ]

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.


Original Secondary Outcome: Same as current

Information By: University of Pittsburgh

Dates:
Date Received: December 21, 2012
Date Started: June 2012
Date Completion: September 2017
Last Updated: February 23, 2017
Last Verified: February 2017