Facial Injuries Clinical Trial
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
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.
The primary objective of the proposed clinical investigation of the Tissue Genesis Cell
Isolation System™ (TGI 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 stromal vascular fraction (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 3-dimensional (3D)
photography, and high resolution computed tomography (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.
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