Adipose Derived Stem Cells in Facial Fat Grafting (SVF)

A Phase II Double-blind, Randomized, Study to Assess the Efficacy of Facial Fat Grafts Supplemented With Autologous, Adipose Derived Stromal Vascular Fraction (SVF)

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.

Study Overview

• Status: Completed
• Conditions: Facial Atrophy
• Intervention / Treatment: Biological: Stromal Vasular Fraction; Procedure: Biopsy

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Delmont, Pennsylvania, United States, 15601
      • Delmont Surgery Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Stromal Vascular Fraction; Subjects will receive stromal vascular fraction assisted fat transfer.	Biological: Stromal Vasular Fraction; The stromal vascular fraction obtained from adipose tissue will be added to the graft; Other Names: Stromal Vascular Fraction; Adiployx; Procedure: 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
ACTIVE_COMPARATOR: Biopsy for Control -regular fat transfer; Subjects will receive regular fat transfer. A biopsy procedure will analyzes the different between experimental and control groups.	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume retention	To demonstrate that SVF administration, in concert with autologous facial fat grafts, is more efficacious, with regards to graft survival, than standard, non-SVF enhanced, autologous facial fat grafts	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants ith autologous facial fat grafts via laboratory results	To monitor the safety of SVF administration along with autologous facial fat grafts via laboratory results	36 months
Changes in the quality of skin	a blinded and independent investigator will assess any changes to the quality of skin	12 months

Collaborators and Investigators

• Sponsor: Antria
• Investigators: Study Director: Shahram Rahimian, MD, Antria

Publications and helpful links

Helpful Links

• Sponsor's website
• Site's website

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2015
• Primary Completion (ACTUAL): July 1, 2017
• Study Completion (ACTUAL): July 1, 2017

Study Registration Dates

• First Submitted: August 11, 2015
• First Submitted That Met QC Criteria: August 15, 2015
• First Posted (ESTIMATE): August 18, 2015

Study Record Updates

• Last Update Posted (ACTUAL): February 27, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Adult; Autologous; Collagenase; Stromal Vascular Fraction; Adipose Derived Stem Cells; Facial Atrophy
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Anatomical; Atrophy; Facies
• Other Study ID Numbers: SSVF0002