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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.
. 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.
. Subjects with life-expectancies less than 9 months