Trial | NCT01828723  Report issue

Title

Safety Study of Antria Cell Preparation Process to Enhance Facial Fat Grafting With Adipose Derived Stem Cells
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)

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    6
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.
Study Started
Apr 30
2013
Primary Completion
Jan 31
2015
Study Completion
Jan 31
2015
Last Update
Jan 27
2015
Estimate

Biological SVF

SVF-Enriched Lipoinjection Experimental

  • Biological SVF

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.
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
No Results Posted