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.

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.

Inclusion Criteria:

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

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

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

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

5. 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.

6. 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).

2. Active infection anywhere in the body

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

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

5. 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.

6. 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

7. Subjects with known alcohol or narcotic drug dependency

8. 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)

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

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

11. 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.