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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.
Human Adipose Tissue is considered as a new source for Stromal Stem Cells and offers a large therapeutic potential for many rare and common diseases that impacts millions of patients worldwide. The Stromal Vascular Fraction (SVF) of Adipose Tissue is relatively easy to extract with minimally invasive procedures such as elective liposuction in large quantities and therefore may be a cost effective source for cellular therapies in a wide range of medical specialties.
The term "Facial Atrophy" describes the lost of subcutaneous fat within the face and can be a result of the aging process as well as some pathological diseases. It can be corrected via autologous fat transfer but usually the majority of the grafted cells will die after 6-12 months. Several publications demonstrate that the addition of SVF cells to the graft may enhance the graft survival.
This double blind, randomized study aims to demonstrated the efficacy of Antria Cell Preparation Process in autologous facial fat grafting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stromal Vascular Fraction | Experimental | Subjects will receive stromal vascular fraction assisted fat transfer. |
|
| Biopsy for Control -regular fat transfer | Active Comparator | Subjects will receive regular fat transfer. A biopsy procedure will analyzes the different between experimental and control groups. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stromal Vasular Fraction | Biological | The stromal vascular fraction obtained from adipose tissue will be added to the graft |
|
| Measure | Description | Time Frame |
|---|---|---|
| Volume retention | To demonstrate that SVF administration, in concert with autologous facial fat grafts, is more efficacious, with regards to graft survival, than standard, non-SVF enhanced, autologous facial fat grafts | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants ith autologous facial fat grafts via laboratory results | To monitor the safety of SVF administration along with autologous facial fat grafts via laboratory results | 36 months |
| Changes in the quality of skin |
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Inclusion Criteria:
Exclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Shahram Rahimian, MD | Antria | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Delmont Surgery Center | Delmont | Pennsylvania | 15601 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39314107 | Derived | Bustos SS, Vyas K, Huang TCT, Suchyta M, LeBrasseur N, Cotofana S, Wyles SP, Mardini S. Pharmacologic and Other Noninvasive Treatments of the Aging Face: A Review of the Current Evidence. Plast Reconstr Surg. 2024 Oct 1;154(4):829e-842e. doi: 10.1097/PRS.0000000000010767. Epub 2023 May 26. |
| Label | URL |
|---|---|
| Sponsor's website | View source |
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| ID | Term |
|---|---|
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| Biopsy | Procedure | A subgroup of each arm (2 subjects from each arm) will undergo a fat transfer behind each ear to be removed via biopsy after 12 months |
|
a blinded and independent investigator will assess any changes to the quality of skin
| 12 months |
| Site's website | View source |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |