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CompletedNCT02526576SVFUpdated Feb 27, 2019

Adipose Derived Stem Cells in Facial Fat Grafting

A Phase 2 interventional study of Stromal Vasular Fraction and Biopsy in Facial Atrophy, sponsored by Antria. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-02-27.

Sponsored by Antria · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Facial Atrophy

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Keywords

  • Facial Atrophy
  • Autologous
  • Adult
  • Adipose Derived Stem Cells
  • Stromal Vascular Fraction
  • Collagenase
03

In context

Atrophy

828 studies on the registry are indexed under Atrophy; 122 are open to participants now.

This study's enrollment of 34 is close to the median of 34 across 603 interventional studies indexed under Atrophy.

Browse Atrophy studies →

Lead sponsor

Antria is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Stromal Vascular Fraction

    Subjects will receive stromal vascular fraction assisted fat transfer.

    Biological: Stromal Vasular Fraction · Procedure: Biopsy

  • 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

Interventions

  • BiologicalStromal Vasular Fraction

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

    Also known as: Stromal Vascular Fraction, Adiployx

  • ProcedureBiopsy

    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

06

What researchers measure

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

    Time frame: 12 months

Secondary outcomes

  1. 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

    Time frame: 36 months

  2. Changes in the quality of skin

    a blinded and independent investigator will assess any changes to the quality of skin

    Time frame: 12 months

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Study locations

1 site
  • Delmont Surgery Center
    Delmont, Pennsylvania 15601, United States
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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02526576
Lead sponsor
Antria
Responsible party
Sponsor
First posted
Aug 18, 2015
Start date
Aug 2015
Primary completion
Jul 2017
Completion
Jul 2017
Last update
Feb 27, 2019

Study contacts

Shahram Rahimian, MD
study director · Antria

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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