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Adipose Derived Stem Cells in Facial Fat Grafting (SVF)

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ClinicalTrials.gov Identifier: NCT02526576
Recruitment Status : Completed
First Posted : August 18, 2015
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Antria

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.

Condition or disease Intervention/treatment Phase
Facial Atrophy Biological: Stromal Vasular Fraction Procedure: Biopsy Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II Double-blind, Randomized, Study to Assess the Efficacy of Facial Fat Grafts Supplemented With Autologous, Adipose Derived Stromal Vascular Fraction (SVF)
Actual Study Start Date : August 2015
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

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




Primary Outcome Measures :
  1. Volume retention [ Time Frame: 12 months ]
    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


Secondary Outcome Measures :
  1. Number of Participants ith autologous facial fat grafts via laboratory results [ Time Frame: 36 months ]
    To monitor the safety of SVF administration along with autologous facial fat grafts via laboratory results

  2. Changes in the quality of skin [ Time Frame: 12 months ]
    a blinded and independent investigator will assess any changes to the quality of skin



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02526576


Locations
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United States, Pennsylvania
Delmont Surgery Center
Delmont, Pennsylvania, United States, 15601
Sponsors and Collaborators
Antria
Investigators
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Study Director: Shahram Rahimian, MD Antria

Additional Information:
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Responsible Party: Antria
ClinicalTrials.gov Identifier: NCT02526576     History of Changes
Other Study ID Numbers: SSVF0002
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019

Keywords provided by Antria:
Facial Atrophy
Autologous
Adult
Adipose Derived Stem Cells
Stromal Vascular Fraction
Collagenase

Additional relevant MeSH terms:
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Atrophy
Facies
Pathological Conditions, Anatomical
Disease Attributes
Pathologic Processes