Safety Study of Antria Cell Preparation Process to Enhance Facial Fat Grafting With Adipose Deriv… (NCT01828723) | Clinical Trial Compass
CompletedPhase 1
Safety Study of Antria Cell Preparation Process to Enhance Facial Fat Grafting With Adipose Derived Stem Cells
United States6 participantsStarted 2013-04
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Female or Male, Age 18 years or older
✓. Subjects that are scheduled for liposuction and facial fat grafting procedures for cosmetic purposes
✓. Facial volume defects which could be treated with a total graft volume of between 1mL and 50mL
✓. BMI between and including 23 and 28
✓. Able to understand and provide written and verbal informed consent
Exclusion criteria
✕. Currently taking or have taken NSAIDs within last two weeks or corticosteroids within the last six weeks prior to screening
✕. Diagnosis of any of the following medical conditions:
✕. 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)
✕. Subjects with a known drug or alcohol dependence within the past 12 months as judged by the Investigator
✕. Subjects with major illnesses involving the renal, hepatic, cardiovascular, and/or nervous systems
✕. Subjects with elevated kidney and/or liver functions
✕. 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.
What they're measuring
1
To evaluate the safety of the administration of a concentrated SVF-enriched fat graft by monitoring the number and types of adverse events, and via physical examinations, vital signs, 12-lead ECGs, blood draws (CBC/LFT/BMP), and urinalysis.