NCT01924364

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: J. Peter Rubin, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Facial Injuries
• Tissue Injury

Interventions

Type	Name	Description
DEVICE	Tissue Genesis Cell Isolation System™ (TGI 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, NCT01345591) will be used for comparison.
PROCEDURE	Standard of care fat grafting	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.

Timeline

• Start date: 2012-06-30
• Primary completion: 2016-09-28
• Completion: 2016-09-28
• First posted: 2013-08-16
• Last updated: 2018-05-11
• Results posted: 2018-05-11

Locations

1 site across 1 country: United States