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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SVF-Enriched Lipoinjection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SVF | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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.
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 such as protease inhibitors (ritonavir, indinavir, nelfinavir, saquinavir), macrolide antibiotics (clarithromycin, telithromycin), chloramphenicol, azole antibiotics (ketoconazole, itraconazole) and nefazodone.
Subjects with a history of keloids or hypertrophic scar formations
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| Name | Affiliation | Role |
|---|---|---|
| Shahram Rahimian, MD, PhD | Antria Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Delmont Surgery Center | Greensburg | Pennsylvania | 15601 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 25, 2019 | |
| Reset | May 20, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 25, 2019 | May 20, 2019 |
| ID | Term |
|---|---|
| D008060 | Lipodystrophy |
| ID | Term |
|---|---|
| D012875 | Skin Diseases, Metabolic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D052439 | Lipid Metabolism Disorders |
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| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |