Adipose Derived Stem Cells in Facial Fat Grafting

Human Adipose Tissue is considered as a new source for Stromal Stem Cells and offers a large
therapeutic potential for many rare and common diseases that impacts millions of patients
worldwide. The Stromal Vascular Fraction (SVF) of Adipose Tissue is relatively easy to
extract with minimally invasive procedures such as elective liposuction in large quantities
and therefore may be a cost effective source for cellular therapies in a wide range of
medical specialties.

The term "Facial Atrophy" describes the lost of subcutaneous fat within the face and can be a
result of the aging process as well as some pathological diseases. It can be corrected via
autologous fat transfer but usually the majority of the grafted cells will die after 6-12
months. Several publications demonstrate that the addition of SVF cells to the graft may
enhance the graft survival.

This double blind, randomized study aims to demonstrated the efficacy of Antria Cell
Preparation Process in autologous facial fat grafting.

Inclusion Criteria:

1. Female or Male, Age 18 to 70 years old

2. Subjects that are eligible for liposuction and facial fat grafting procedures for
cosmetic purposes and facial atrophy.

3. Subjects must require augmentation to the infra-malar region. Furthermore, facial
engraftment to additional, non-study related regions is optional, but not required.

4. Inframalar Atrophy Assessment Scale of 2 to 4

5. Facial volume defect range: 2 to 10 mL

6. Body Mass Index (BMI) between and including 22 and 29

7. Able to understand and provide written and verbal informed consent

8. Fitzpatrick Scale 1 to 6

Exclusion Criteria:

1. Currently taking or have taken None Steroid Anti-inflammatory Drugs (NSAIDs) within
last two weeks or corticosteroids within the last six weeks prior to screening

2. Diagnosis of any of the following medical conditions:

- Active malignancy (diagnosed within 5 years), except for treated non-melanoma
skin cancer or other non-invasive or in-situ neoplasm (e.g. cervical cancer)

- Active infection

- Type I or Type II Diabetes

- Skin/Bone deformities in the face, including scaring or hyperpigmentation within
the graft site.

3. Subjects who are unlikely to comply with the protocol (e.g., uncooperative attitude,
inability to return for subsequent visits, dementia, and/or otherwise considered by
the Investigator to be unlikely to complete the study)

4. Subjects with a known drug or alcohol dependence within the past 12 months as judged
by the Investigator

5. Dermal fillers or facial reconstruction within the past 24 months, Subjects must also
refrain from such procedures during the duration of the study.

6. Subjects with major illnesses involving the renal, hepatic, cardiovascular, and/or
nervous systems.

7. Subjects with elevated kidney and/or liver functions

8. Any other disease condition or laboratory results that in the opinion of the
investigator may be clinically significant and render the subject inappropriate for
the study procedure(s), may alter the accuracy of study results, or increase risk for
subjects.

9. Subjects with life-expectancies less than 9 months

10. Subjects with known collagenase allergies

11. Subjects with idiopathic or drug-induced coagulopathy

12. Pregnant females

13. On radiotherapy or chemotherapy agents

14. Taking strong CYP450 inhibitors

15. Subjects with a history of keloids or hypertrophic scar formations

16. Previous treatment with any synthetic fillers in the inframalar area