Use of Concentrated Endogenous Autologous Adipose Stromal Cells in Fat Grafts for Craniofacial Trauma

Craniofacial injuries have serious psychosocial sequele and affect quality of life. Many
individuals who suffer significant facial disfigurement from injury experience psychological
distress and impairment in functioning not limited to the acute phase of injury, but over a
longer term period of treatment, recovery, and adjustment. Until recently, treatment of
disfiguring craniofacial injuries has been mostly limited to surgical flap procedures,
microsurgical tissue transfer, and implantable prostheses. However, these methods can leave
conspicuous scars on the face and the donor site, and in the case of implants can lead to
complications associated with foreign materials. Autologous fat grafting with minimally
invasive cannulas is a procedure that has been used for decades in common plastic surgery
practice for facial aesthetic procedures. This technique is also a promising treatment for
soft tissue reconstruction after craniofacial trauma because the graft harvest and injection
are minimally invasive. The treatment is performed by using a small liposuction cannula to
aspirate fat tissue from the donor site, and then re-injecting the fat into the recipient
site with specialized injection cannulas. After harvest, and prior to injection, the fat
graft is subjected to a mechanical processing step to separate the aqueous layer and
concentrate the adipocytes. This often takes the form of centrifugation or filtering.

The main problem with autologous fat grafting is a variable resorption of the graft volume
over time. As much as 30-60% of the graft volume can diminish over time. Many variables may
influence the behavior of clinical fat grafts, including harvest site, harvest technique,
graft preparation, and injection technique.

Concentrating the already present autologous adipose stromal cells within the fat grafts is
not expected to increase subject risk levels beyond the risk levels of the application of
fat grafts. We are currently approved for the application of fat grafts with concentrated
autologous adipose stromal cells [IRB#10100293]. This proposal uses an increased
concentration of adipose stromal cells compared to the above referenced study; no increase
of risk to the subject is anticipated. We hypothesize that fat grafting for facial trauma,
facilitated by enhancing graft quality with a higher concentration of endogenous autologous
vascular adipose stromal cells in the grafted tissue, will enhance the successful
restoration of tissue volume and craniofacial form. The use of a higher concentration of
autologous adipose stromal cells may lead to lower fat resorption rates that may be observed
in the approved IRB study [PRO10100293]. Additionally, we hypothesize that the clinical
results using the concentrated autologous stromal vascular cells will be durable and the
subject's quality of life scores will be improved compared to subjects who have had fat
grafting alone using historical controls.

Inclusion Criteria:

1. Aged 18 years 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 an uninjured regions with fat grafts
in order to obtain symmetry or balance.

6. Willing and able to comply with follow up examinations,

Exclusion Criteria:

1. Age less than 18 years

2. Inability to provide informed consent

3. 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).

4. Active infection anywhere in the body

5. Diagnosed with cancer within the last 12 months and/or presently receiving
chemotherapy or radiation treatment

6. Known coagulopathy

7. Systemic disease that would render the fat harvest and injection procedure, along
with associated anesthesia, unsafe to the patient.

8. Pregnancy

9. Diagnosis of Schizophrenia or Bipolar Disorder