PI J. Peter Rubin

Title Biomedical Translational Initiative: Structural Fat Grafting for Craniofacial Trauma

Description Facial trauma injuries, especially those sustained in military combat, are characterized by destruction of bone and soft tissue anatomy. While the bony skeleton can often be reconstructed, the overlying soft tissue is difficult to restore. Importantly, it is the structure of the soft tissue that imparts the normal human form, and adequate reconstruction of soft tissue defects allows trauma victims to reintegrate into society. Current procedures for soft tissue reconstruction of the face primarily involve tissue flap reconstruction procedures. Synthetic (e.g silicone) implants for soft tissue trauma of the face have no practical role and are fraught with complications and poor results. Tissue flap operations are extensive, often including microvascular surgery, and do not precisely correct the deformities. Autologous fat grafting, performed through a minimally invasive means, has the potential to correct deformities with much greater precision and lower morbidity.

While autologous adipose tissue grafting may provide a minimally invasive means of accurately restoring facial soft tissue structure after trauma, graft resorption is a significant limitation. In this study, we capitalize upon two enabling technologies to make fat grafting effective for the wounded soldier and validate outcomes: 1) Specialized instrumentation for fat tissue harvest (Lipokit, Medi-Khan USA, Inc , California) that concentrates adipose stem cells, and 2) Specialized instrumentation for fat tissue injection (Coleman Cannula System, Mentor Medical, California) that allow for precise placement of appropriately sized aliquots of fat within the injured tissues and adjust to irregularly shaped and scarred tissue beds. Both of these devices are approved by the FDA.

We hypothesize that results from fat grafting for facial trauma, made possible by these two enabling technologies, will show good restoration of tissue volume and craniofacial form. Additionally, we hypothesize that the results will be durable and patient quality of life improved. Validation will be accompanied by a plan to make this technology broadly available to physicians treating combat injuries.

The specific aims of the study are:

  • Treat disfiguring craniofacial injuries in 20 soldiers with fat grafting 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 9 months after treatment to define long term outcomes.
  • 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.
  • Measure quality of life in patients before and after autologous fat grafting using validated psychosocial measures.

Source Department of Defense

Term 10/01/09 to 3/31/2010

Amount: $1,618,653 ($1,141,964 direct / $ 476,689 indirect)