Safety Study of Antria Cell Preparation Process to Enhance Facial Fat Grafting With Adipose Derived Stem Cells
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies, Cosmetic, Endocrine |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Endocrinology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/7/2015 |
| Start Date: | April 2013 |
| End Date: | November 2013 |
| Contact: | Shahram Rahimian, MD, PhD |
| Email: | srahimian@antria.org |
| Phone: | 814-691-7377 |
A Phase One, Open Label, Single Arm Study to Demonstrate the Safety of Antria Cell Preparation Process During Facial Fat Grafting Assisted With Autologous, Adipose Derived Stromal Vascular Fraction (SVF)
The primary purpose of this study is to demonstrate the safety of injecting the Stromal
Vascular Fraction (SVF) [containing Adipose Derived Stem Cells (ADSCs)] enriched fat grafts
into regions of the face that require enhancement. The safety of SVF will be evaluated
throughout the course of the study phase through the assessment of laboratory values,
physical examinations, adverse events, safety phone calls etc.
Vascular Fraction (SVF) [containing Adipose Derived Stem Cells (ADSCs)] enriched fat grafts
into regions of the face that require enhancement. The safety of SVF will be evaluated
throughout the course of the study phase through the assessment of laboratory values,
physical examinations, adverse events, safety phone calls etc.
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
We found this trial at
1
site
Click here to add this to my saved trials
