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

Aging Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01828723
• Other study ID #: SSVF0001
• Status: Completed
• Phase: Phase 1
• First received: April 2, 2013
• Last updated: January 26, 2015
• Start date: April 2013
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: Antria
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aging
• Lipoatrophy
• Wrinkles

Intervention

Biological:
• SVF

Locations

Country	Name	City	State
United States	Delmont Surgery Center	Greensburg	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Antria

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No