Facial AtrophyPhase 2SVFNCT02526576
Adipose Derived Stem Cells in Facial Fat Grafting
A Phase 2 study testing Stromal Vasular Fraction and Biopsy in people with Facial Atrophy, run by Antria at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Facial Atrophy
- What is being tested?
- Stromal Vasular Fraction and Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Jul 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
- Pregnant females
- On radiotherapy or chemotherapy agents
- Taking strong CYP450 inhibitors
- Subjects with a history of keloids or hypertrophic scar formations
- Previous treatment with any synthetic fillers in the inframalar area
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Conditions
- Facial Atrophy
- Being tested
- Stromal Vasular Fraction, Biopsy
- Keywords
- Facial Atrophy, Autologous, Adult, Adipose Derived Stem Cells, Stromal Vascular Fraction, Collagenase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stromal Vasular FractionBiological
Also called Stromal Vascular Fraction, Adiployx
The stromal vascular fraction obtained from adipose tissue will be added to the graft
BiopsyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Stromal Vascular Fraction | Experimental | Subjects will receive stromal vascular fraction assisted fat transfer. Receives: 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. Receives: Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (2)
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
Measured: 36 months
Changes in the quality of skin
a blinded and independent investigator will assess any changes to the quality of skin
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Facial AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antria
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shahram Rahimian, MD, Study director, Antria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02526576
- Sponsor's protocol ID
- SSVF0002
- Acronym
- SVF
- Status last verified
- Feb 2019
- First submitted
- 11 Aug 2015
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 39314107
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02526576
- Acronym / sponsor ID
- SVF / SSVF0002
- Conditions
- Facial Atrophy
- Keywords
- Facial Atrophy, Autologous, Adult, Adipose Derived Stem Cells, Stromal Vascular Fraction, Collagenase
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- AntriaIndustry (pharma, biotech, devices)
- Study start
- Aug 2015 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 18 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stromal Vascular Fraction | Experimental | Biological: Stromal Vasular Fraction, Procedure: BiopsySubjects will receive stromal vascular fraction assisted fat transfer. |
| Biopsy for Control -regular fat transfer | Active comparator | Procedure: BiopsySubjects will receive regular fat transfer. A biopsy procedure will analyzes the different between experimental and control groups. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (20 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stromal Vasular FractionAlso: Stromal Vascular Fraction, AdiployxThe stromal vascular fraction obtained from adipose tissue will be added to the graft | Biological | Stromal Vascular Fraction |
| BiopsyA 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 | Procedure or surgery | Biopsy for Control -regular fat transfer, Stromal Vascular Fraction |
Primary outcome
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
2 secondary outcomes
Number of Participants ith autologous facial fat grafts via laboratory results
Time frame: 36 months
Changes in the quality of skin
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Derived from this study: PubMed 39314107Bustos 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.
- Sponsor's websiteLink provided by the sponsor.
- Site's websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shahram Rahimian, MD study director
Antria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stromal Vasular Fraction and Biopsy in people with Facial Atrophy, run by Antria at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume retention (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02526576, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.