Safety Study of Antria Cell Preparation Process to Enhance Facial Fat Grafting With Adipose Derived Stem Cells

This is an interventional treatment trial for Lipoatrophy focused on measuring Autologous Adult Stem Cell, Adipose Derived Stem Cell, Stromal Vascular Fraction, SVF, Antria, Shah Rahimian, Leonard Maliver, David Bizousky, Rahul Gore, Lee Quist, Dudley McNitt Read More

Inclusion Criteria:

1. Female or Male, Age 18 years or older
2. Subjects that are scheduled for liposuction and facial fat grafting procedures for cosmetic purposes
3. Facial volume defects which could be treated with a total graft volume of between 1mL and 50mL
4. BMI between and including 23 and 28
5. Able to understand and provide written and verbal informed consent

Exclusion Criteria:

1. Currently taking or have taken 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
   • Active infection
   • Type I or Type II Diabetes
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. Subjects with major illnesses involving the renal, hepatic, cardiovascular, and/or nervous systems
6. Subjects with elevated kidney and/or liver functions
7. 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.
8. Subjects with life-expectancies less than 9 months
9. Subjects with known collagenase allergies
10. Subjects with idiopathic or drug-induced coagulopathy
11. Pregnant females
12. On radiotherapy or chemotherapy agents
13. Taking strong CYP450 inhibitors such as protease inhibitors (ritonavir, indinavir, nelfinavir, saquinavir), macrolide antibiotics (clarithromycin, telithromycin), chloramphenicol, azole antibiotics (ketoconazole, itraconazole) and nefazodone.
14. Subjects with a history of keloids or hypertrophic scar formations