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

Sponsor

Antria (Industry)

Overall Status

Completed

CT.gov ID

NCT01828723

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lipoatrophy Aging Wrinkles	Biological: SVF	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

6 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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)

Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SVF-Enriched Lipoinjection	Biological: SVF

Arm

Intervention/Treatment

Experimental: SVF-Enriched Lipoinjection

Biological: SVF

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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