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)

Antria1 site in 1 country6 target enrollmentApril 2013

ConditionsLipoatrophy Aging Wrinkles

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Lipoatrophy
Sponsor: Antria
Enrollment: 6
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 2013

End Date

January 2015

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Antria

Responsible Party

Sponsor

Eligibility Criteria

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:
•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
•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.

Outcomes

Primary Outcomes

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.

Time Frame: 6 months

Secondary Outcomes

To demonstrate the efficacy of the addition of autologous SVF isolated via Antria Cell Preparation Process by observing graft survival time, volume, and quality of facial re-contouring(6 months)