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

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.

• 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.
• 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.

Inclusion criteria

• 1. Subjects who are male or female, military or civilian, 18 years of age or older and able to provide informed consent

• Have suffered injury resulting in craniofacial volume defects which could be treated with a graft volume of between 3 and 100 cc of lipoaspirate

• Be at least 3 months post-injury or post-surgery (from trauma procedures) so that acute edema is resolved

• Volume defects are covered by intact skin and do not communicate with oral cavity or sinuses

• 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.

• 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).

• Active infection anywhere in the body

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

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

• 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.

• 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

• Subjects with known alcohol or narcotic drug dependency

• 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)

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

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

• 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.