Adipose Derived Stem Cells in Facial Fat Grafting

Completed · Phase 2

Conditions studied: Facial Atrophy

In brief

This phase two, randomized, double-blind study is designed to demonstrate the enhanced efficacy of SVF-enriched autologous facial fat grafts, in relation to standard, non-SVF enriched, facial fat grafts by evaluating volumetric retention and contour of the engrafted region over the course of one year.

Key facts

Study ID

NCT02526576

Run by

Antria

People needed

34

Starts

2015-08-01

Expected to finish

2017-07-01

Last updated by the study team

2019-02-27

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Female or Male, Age 18 to 70 years old
• Subjects that are eligible for liposuction and facial fat grafting procedures for cosmetic purposes and facial atrophy.
• Subjects must require augmentation to the infra-malar region. Furthermore, facial engraftment to additional, non-study related regions is optional, but not required.
• Inframalar Atrophy Assessment Scale of 2 to 4
• Facial volume defect range: 2 to 10 mL
• Body Mass Index (BMI) between and including 22 and 29
• Able to understand and provide written and verbal informed consent
• Fitzpatrick Scale 1 to 6

You may not qualify if…

• 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
• 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.
• 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
• Dermal fillers or facial reconstruction within the past 24 months, Subjects must also refrain from such procedures during the duration of the study.
• 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.
• Subjects with life-expectancies less than 9 months
• Subjects with known collagenase allergies
• Subjects with idiopathic or drug-induced coagulopathy
• Pregnant females
• On radiotherapy or chemotherapy agents
• Taking strong CYP450 inhibitors
• Subjects with a history of keloids or hypertrophic scar formations
• Previous treatment with any synthetic fillers in the inframalar area

Where it is running

• Delmont Surgery Center — Delmont, Pennsylvania, United States

Full record on ClinicalTrials.gov

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