Adipose Derived Stem Cells in Facial Fat Grafting

NCT02526576 | Completed Phase 2

• 1 other identifier: SSVF0002
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Facial Atrophy

Keywords

Facial Atrophy; Autologous; Adult; Adipose Derived Stem Cells; Stromal Vascular Fraction; Collagenase

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Participants ith autologous facial fat grafts via laboratory results

  36 months

• Changes in the quality of skin

  12 months

Study Arms (2)

Stromal Vascular Fraction

EXPERIMENTAL

Subjects will receive stromal vascular fraction assisted fat transfer.

Biological: Stromal Vasular Fraction; Procedure: Biopsy

Biopsy for Control -regular fat transfer

ACTIVE COMPARATOR

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

Procedure: Biopsy

Interventions

Stromal Vasular Fraction BIOLOGICAL

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

Also known as: Stromal Vascular Fraction, Adiployx

Stromal Vascular Fraction

Biopsy 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; Stromal Vascular Fraction

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or Male, Age 18 to 70 years old
• Subjects that are eligible for liposuction and facial fat grafting procedures for cosmetic purposes and facial atrophy.
• Subjects must require augmentation to the infra-malar region. Furthermore, facial engraftment to additional, non-study related regions is optional, but not required.
• Inframalar Atrophy Assessment Scale of 2 to 4
• Facial volume defect range: 2 to 10 mL
• Body Mass Index (BMI) between and including 22 and 29
• Able to understand and provide written and verbal informed consent
• Fitzpatrick Scale 1 to 6

You may not qualify if:

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

Sponsors & Collaborators

• Antria: lead

Study Sites (1)

Delmont Surgery Center

Delmont, Pennsylvania, 15601, United States

Location

Related Publications (1)

• 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.

  PMID: 39314107 DERIVED

Related Links

• Sponsor's website
• Site's website

MeSH Terms

Interventions

Biopsy

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Shahram Rahimian, MD

  Antria

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2015
• First Posted: August 18, 2015
• Study Start: August 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: February 27, 2019

Record last verified: 2019-02

Locations

US (1)