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

NCT ID: NCT01828723

Last Updated: 2015-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2015-01-31

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.

Conditions

Lipoatrophy; Aging; Wrinkles

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SVF-Enriched Lipoinjection

Group Type: EXPERIMENTAL

SVF

Intervention Type: BIOLOGICAL

Interventions

SVF

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Female or Male, Age 18 years or older

2. Subjects that are scheduled for liposuction and facial fat grafting procedures for cosmetic purposes

3. Facial volume defects which could be treated with a total graft volume of between 1mL and 50mL

4. BMI between and including 23 and 28

5. Able to understand and provide written and verbal informed consent

Exclusion Criteria

1. Currently taking or have taken NSAIDs within last two weeks or corticosteroids within the last six weeks prior to screening

2. 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

3. 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)

4. Subjects with a known drug or alcohol dependence within the past 12 months as judged by the Investigator

5. Subjects with major illnesses involving the renal, hepatic, cardiovascular, and/or nervous systems

6. Subjects with elevated kidney and/or liver functions

7. 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.

8. Subjects with life-expectancies less than 9 months

9. Subjects with known collagenase allergies

10. Subjects with idiopathic or drug-induced coagulopathy

11. Pregnant females

12. On radiotherapy or chemotherapy agents

13. Taking strong CYP450 inhibitors such as protease inhibitors (ritonavir, indinavir, nelfinavir, saquinavir), macrolide antibiotics (clarithromycin, telithromycin), chloramphenicol, azole antibiotics (ketoconazole, itraconazole) and nefazodone.

14. Subjects with a history of keloids or hypertrophic scar formations

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Antria

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shahram Rahimian, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Antria Inc.

Locations

Delmont Surgery Center

Greensburg, Pennsylvania, United States

Countries

United States

Other Identifiers

SSVF0001

Identifier Type: -

Identifier Source: org_study_id