Adipose Derived Stem Cells in Facial Fat Grafting

NCT ID: NCT02526576

Last Updated: 2019-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2017-07-31

Brief Summary

This phase two, randomized, double-blind study is designed to demonstrate the enhanced efficacy of SVF-enriched autologous facial fat grafts, in relation to standard, non-SVF enriched, facial fat grafts by evaluating volumetric retention and contour of the engrafted region over the course of one year.

Detailed Description

Human Adipose Tissue is considered as a new source for Stromal Stem Cells and offers a large therapeutic potential for many rare and common diseases that impacts millions of patients worldwide. The Stromal Vascular Fraction (SVF) of Adipose Tissue is relatively easy to extract with minimally invasive procedures such as elective liposuction in large quantities and therefore may be a cost effective source for cellular therapies in a wide range of medical specialties.

The term "Facial Atrophy" describes the lost of subcutaneous fat within the face and can be a result of the aging process as well as some pathological diseases. It can be corrected via autologous fat transfer but usually the majority of the grafted cells will die after 6-12 months. Several publications demonstrate that the addition of SVF cells to the graft may enhance the graft survival.

This double blind, randomized study aims to demonstrated the efficacy of Antria Cell Preparation Process in autologous facial fat grafting.

Conditions

Facial Atrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Stromal Vascular Fraction

Subjects will receive stromal vascular fraction assisted fat transfer.

Group Type: EXPERIMENTAL

Stromal Vasular Fraction

Intervention Type: BIOLOGICAL

The stromal vascular fraction obtained from adipose tissue will be added to the graft

Biopsy

Intervention Type: PROCEDURE

A subgroup of each arm (2 subjects from each arm) will undergo a fat transfer behind each ear to be removed via biopsy after 12 months

Biopsy for Control -regular fat transfer

Subjects will receive regular fat transfer. A biopsy procedure will analyzes the different between experimental and control groups.

Group Type: ACTIVE_COMPARATOR

Biopsy

Intervention Type: PROCEDURE

A subgroup of each arm (2 subjects from each arm) will undergo a fat transfer behind each ear to be removed via biopsy after 12 months

Interventions

Stromal Vasular Fraction

The stromal vascular fraction obtained from adipose tissue will be added to the graft

Intervention Type: BIOLOGICAL

Biopsy

A subgroup of each arm (2 subjects from each arm) will undergo a fat transfer behind each ear to be removed via biopsy after 12 months

Intervention Type: PROCEDURE

Other Intervention Names

Stromal Vascular Fraction; Adiployx

Eligibility Criteria

Inclusion Criteria

1. Female or Male, Age 18 to 70 years old

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

3. Subjects must require augmentation to the infra-malar region. Furthermore, facial engraftment to additional, non-study related regions is optional, but not required.

4. Inframalar Atrophy Assessment Scale of 2 to 4

5. Facial volume defect range: 2 to 10 mL

6. Body Mass Index (BMI) between and including 22 and 29

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

8. Fitzpatrick Scale 1 to 6

Exclusion Criteria

1. Currently taking or have taken None Steroid Anti-inflammatory Drugs (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 (e.g. cervical cancer)
• Active infection
• Type I or Type II Diabetes
• Skin/Bone deformities in the face, including scaring or hyperpigmentation within the graft site.

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. Dermal fillers or facial reconstruction within the past 24 months, Subjects must also refrain from such procedures during the duration of the study.

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

7. Subjects with elevated kidney and/or liver functions

8. 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.

9. Subjects with life-expectancies less than 9 months

10. Subjects with known collagenase allergies

11. Subjects with idiopathic or drug-induced coagulopathy

12. Pregnant females

13. On radiotherapy or chemotherapy agents

14. Taking strong CYP450 inhibitors

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

16. Previous treatment with any synthetic fillers in the inframalar area

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Antria

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shahram Rahimian, MD

Role: STUDY_DIRECTOR

Antria

Locations

Delmont Surgery Center

Delmont, Pennsylvania, United States

Countries

United States

References

Bustos SS, Vyas K, Huang TCT, Suchyta M, LeBrasseur N, Cotofana S, Wyles SP, Mardini S. Pharmacologic and Other Noninvasive Treatments of the Aging Face: A Review of the Current Evidence. Plast Reconstr Surg. 2024 Oct 1;154(4):829e-842e. doi: 10.1097/PRS.0000000000010767. Epub 2023 May 26.

Reference Type: DERIVED

PMID: 39314107 (View on PubMed)

Related Links

http://www.antria.org

Sponsor's website

http://artisan-plasticsurgery.com/

Site's website

Other Identifiers

SSVF0002

Identifier Type: -

Identifier Source: org_study_id