LipoatrophyPhase 1NCT01828723
Safety Study of Antria Cell Preparation Process to Enhance Facial Fat Grafting With Adipose Derived Stem Cells
A Phase 1 study testing SVF in people with Lipoatrophy and Aging, run by Antria at 1 site in United States.
Trial summary
The primary purpose of this study is to demonstrate the safety of injecting the Stromal Vascular Fraction (SVF) [containing Adipose Derived Stem Cells (ADSCs)] enriched fat grafts into regions of the face that require enhancement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lipoatrophy, Aging, Wrinkles
- What is being tested?
- SVF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Jan 2015
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or Male, Age 18 years or older
- Subjects that are scheduled for liposuction and facial fat grafting procedures for cosmetic purposes
- Facial volume defects which could be treated with a total graft volume of between 1mL and 50mL
- BMI between and including 23 and 28
- Able to understand and provide written and verbal informed consent
Who cannot join
- Currently taking or have taken 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
- Active infection
- Type I or Type II Diabetes
- 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)
Show all 17Show fewer
- Subjects with a known drug or alcohol dependence within the past 12 months as judged by the Investigator
- 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 such as protease inhibitors (ritonavir, indinavir, nelfinavir, saquinavir), macrolide antibiotics (clarithromycin, telithromycin), chloramphenicol, azole antibiotics (ketoconazole, itraconazole) and nefazodone.
- Subjects with a history of keloids or hypertrophic scar formations
Trial locations and contacts
1 site in 1 country.
United States1 site
Delmont Surgery Center
Greensburg, Pennsylvania, 15601
About this study
Official title: A Phase One, Open Label, Single Arm Study to Demonstrate the Safety of Antria Cell Preparation Process During Facial Fat Grafting Assisted With Autologous, Adipose Derived Stromal Vascular Fraction (SVF)
The primary purpose of this study is to demonstrate the safety of injecting the Stromal Vascular Fraction (SVF) [containing Adipose Derived Stem Cells (ADSCs)] enriched fat grafts into regions of the face that require enhancement. The safety of SVF will be evaluated throughout the course of the study phase through the assessment of laboratory values, physical examinations, adverse events, safety phone calls etc.
- Conditions
- Lipoatrophy, Aging, Wrinkles
- Being tested
- SVF
- Keywords
- Autologous Adult Stem Cell, Adipose Derived Stem Cell, Stromal Vascular Fraction, SVF, Antria, Shah Rahimian, Leonard Maliver, David Bizousky, Rahul Gore, Lee Quist, Dudley McNitt
- Medical subject headings
- Lipodystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SVFBiological
| Study group | Role | What they receive |
|---|---|---|
| SVF-Enriched Lipoinjection | Experimental | Not described Receives: Biological: SVF |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of the administration of a concentrated SVF-enriched fat graft by monitoring the number and types of adverse events, and via physical examinations, vital signs, 12-lead ECGs, blood draws (CBC/LFT/BMP), and urinalysis.
Measured: 6 months
Secondary outcomes (1)
To demonstrate the efficacy of the addition of autologous SVF isolated via Antria Cell Preparation Process by observing graft survival time, volume, and quality of facial re-contouring
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipoatrophyStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antria
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shahram Rahimian, MD, PhD, Principal investigator, Antria Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828723
- Sponsor's protocol ID
- SSVF0001
- Status last verified
- Jan 2015
- First submitted
- 2 Apr 2013
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase One, Open Label, Single Arm Study to Demonstrate the Safety of Antria Cell Preparation Process During Facial Fat Grafting Assisted With Autologous, Adipose Derived Stromal Vascular Fraction (SVF)
- ClinicalTrials.gov ID
- NCT01828723
- Acronym / sponsor ID
- SSVF0001
- Conditions
- Lipoatrophy, Aging, Wrinkles
- Keywords
- Autologous Adult Stem Cell, Adipose Derived Stem Cell, Stromal Vascular Fraction, SVF, Antria, Shah Rahimian, Leonard Maliver, David Bizousky
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- AntriaIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 11 Apr 2013 (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.
The primary purpose of this study is to demonstrate the safety of injecting the Stromal Vascular Fraction (SVF) [containing Adipose Derived Stem Cells (ADSCs)] enriched fat grafts into regions of the face that require enhancement. The safety of SVF will be evaluated throughout the course of the study phase through the assessment of laboratory values, physical examinations, adverse events, safety phone calls etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SVF-Enriched Lipoinjection | Experimental | Biological: SVF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female or Male, Age 18 years or older
- Subjects that are scheduled for liposuction and facial fat grafting procedures for cosmetic purposes
- Facial volume defects which could be treated with a total graft volume of between 1mL and 50mL
- BMI between and including 23 and 28
- Able to understand and provide written and verbal informed consent
Key exclusion criteria (17 listed)
- Currently taking or have taken 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
- Subjects with major illnesses involving the renal, hepatic, cardiovascular, and/or nervous systems
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 |
|---|---|---|
| SVF | Biological | SVF-Enriched Lipoinjection |
Primary outcome
To evaluate the safety of the administration of a concentrated SVF-enriched fat graft by monitoring the number and types of adverse events, and via physical examinations, vital signs, 12-lead ECGs, blood draws (CBC/LFT/BMP), and urinalysis.
Time frame: 6 months
1 secondary outcome
To demonstrate the efficacy of the addition of autologous SVF isolated via Antria Cell Preparation Process by observing graft survival time, volume, and quality of facial re-contouring
Time frame: 6 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 Jan 2015.
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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, PhD principal investigator
Antria Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SVF in people with Lipoatrophy and Aging, 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 5 inclusion and 17 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 Jan 2015. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To evaluate the safety of the administration of a concentrated SVF-enriched fat graft by monitoring the number and types of adverse events, and via physical examinations, vital signs, 12-lead ECGs, blood draws (CBC/LFT/BMP), and urinalysis. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2015.