Breast Hypoplasia and Facial AgeingPhase 3NCT03258164
Cosmetic Fat Transplantation Using Expanded ASC Enriched Fat Grafts
A Phase 3 study testing ASC enriched lipofilling and Standard Lipofilling in people with Breast Hypoplasia and Facial Ageing, run by Stemform at 1 site in Denmark.
Trial summary
The purpose of the present study is to examine whether enrichment of a fat graft with autologous ex vivo expanded ASC injected into the breast tissue or face, both for cosmetic use, will significantly improve the results of conventional lipofilling and synthetic facial fillers, thereby being able to offer a safer… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Hypoplasia and Facial Ageing
- What is being tested?
- ASC enriched lipofilling and Standard Lipofilling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Mar 2017to 22 Nov 2022
- Phase
- Phase 3
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 - 50 years
- Healthy females
- BMI 18 - 30 kg/m2
- 1000 ml of fat (lipoaspirate) available for liposuction at the abdomen and/or thighs
- Desire for breast augmentation
- Speaks and reads Danish or English
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- Signed informed consent
- Age 25 - 65 years
- Healthy females
- BMI 18 - 30 kg/m2
- 100 ml of fat (lipoaspirate) available for liposuction at the abdomen and/or thighs
- Desire for facial wrinkle treatment and facial augmentation (rejuvenation)
- Speaks and reads Danish or English
- Signed informed consent
Who cannot join
- Smoking
- Previous breast surgery
- Previous cancer or predisposition to breast cancer
- Pregnancy or planned pregnancy within one year after the procedure
- Breastfeeding less than 6 months prior to inclusion
- Weight gain or loss above 2 BMI point
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- Known chronic disease associated with metabolism malfunction or pour healing
- Pacemaker or other implanted foreign objects
- Allergy towards necessary anaesthesia
- Intention of weight loss or weight gain within the trial period
- Criteria fascial filling
- Smoking
- Previous facial surgery
- Previous cancer
- Pregnancy or planned pregnancy within one year after the procedure
- Known chronic disease associated with metabolism malfunction or poor healing
- Allergy towards necessary anaesthesia
- Intention of weight loss or weight gain within the trial period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fat Transplantation Enriched With Expanded Adipose-derived Autologous Mesenchymal Stromal Cells in Cosmetic Breast Augmentation and Cosmetic Facial Filling
The purpose of the present study is to examine whether enrichment of a fat graft with autologous ex vivo expanded ASC injected into the breast tissue or face, both for cosmetic use, will significantly improve the results of conventional lipofilling and synthetic facial fillers, thereby being able to offer a safer, more natural and long-lasting alternative to current artificial solutions for cosmetic patients.
Read the detailed description
The cosmetic breast augmentation design is a double-blind (surgeon and data assessor) randomized, prospective clinical study on healthy subjects.
The cosmetic facial filling design is a data assessor-blinded, randomized, prospective clinical study on healthy subjects.
- Conditions
- Breast Hypoplasia and Facial Ageing
- Being tested
- ASC enriched lipofilling, Standard Lipofilling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASC enriched lipofillingBiological
Fat grafts enriched with ex vivo expanded ASC
Standard LipofillingBiological
Non-ASC enriched fat grafts
| Study group | Role | What they receive |
|---|---|---|
| ASC | Experimental | Not described Receives: Biological: ASC enriched lipofilling |
| Control | Active comparator | Not described Receives: Biological: Standard Lipofilling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in volume over time after breast augmentation
Measurement of the residual volume of fat transplants as based on MRI before operation (baseline), and four and twelve months after lipo-injection to the breast in order to determine the difference in volume between baseline and 4 months and 12 months post operative; and thereby the resorption rate over time.
Measured: Baseline, four and twelve months
Secondary outcomes (1)
Change in cosmetic facial appearance over time after facial filling
Assessment of cosmetic outcome based on clinical photos before (baseline), one, four and twelve months after the procedure when compared to baseline, evaluated by 5 independent plastic surgeons blinded to the intervention using a scale of 1-5 to determine the difference in appearance over time.
Measured: Baseline, one, four and twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start22 Mar 2017
- Primary completion24 Oct 2022
- Study completion22 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Hypoplasia and Facial AgeingStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stemform
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aleris-Hamlet Hospitaler København
- Responsible party
- Sponsor
- Investigators
- Stig-Frederik T Kølle, MD, PhD, Principal investigator, Stemform
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03258164
- Sponsor's protocol ID
- H-16046960
- Status last verified
- Nov 2022
- First submitted
- 7 Aug 2017
- Last updated
- 28 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results will be published in international medical journals
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fat Transplantation Enriched With Expanded Adipose-derived Autologous Mesenchymal Stromal Cells in Cosmetic Breast Augmentation and Cosmetic Facial Filling
- ClinicalTrials.gov ID
- NCT03258164
- Acronym / sponsor ID
- H-16046960
- Conditions
- Breast Hypoplasia and Facial Ageing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- StemformIndustry (pharma, biotech, devices)
- Collaborators
- Aleris-Hamlet Hospitaler København
- Study start
- 22 Mar 2017 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 22 Nov 2022 (actual)
- First posted
- 23 Aug 2017 (actual)
- 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 purpose of the present study is to examine whether enrichment of a fat graft with autologous ex vivo expanded ASC injected into the breast tissue or face, both for cosmetic use, will significantly improve the results of conventional lipofilling and synthetic facial fillers, thereby being able to offer a safer, more natural and long-lasting alternative to current artificial solutions for cosmetic patients.
Detailed description
The cosmetic breast augmentation design is a double-blind (surgeon and data assessor) randomized, prospective clinical study on healthy subjects.
The cosmetic facial filling design is a data assessor-blinded, randomized, prospective clinical study on healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASC | Experimental | Biological: ASC enriched lipofilling |
| Control | Active comparator | Biological: Standard Lipofilling |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age 18 - 50 years
- Healthy females
- BMI 18 - 30 kg/m2
- 1000 ml of fat (lipoaspirate) available for liposuction at the abdomen and/or thighs
- Desire for breast augmentation
Key exclusion criteria (18 listed)
- Smoking
- Previous breast surgery
- Previous cancer or predisposition to breast cancer
- Pregnancy or planned pregnancy within one year after the procedure
- Breastfeeding less than 6 months prior to inclusion
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 |
|---|---|---|
| ASC enriched lipofillingFat grafts enriched with ex vivo expanded ASC | Biological | ASC |
| Standard LipofillingNon-ASC enriched fat grafts | Biological | Control |
Primary outcome
Change in volume over time after breast augmentation
Time frame: Baseline, four and twelve months
Measurement of the residual volume of fat transplants as based on MRI before operation (baseline), and four and twelve months after lipo-injection to the breast in order to determine the difference in volume between baseline and 4 months and 12 months post operative; and thereby the resorption rate over time.
1 secondary outcome
Change in cosmetic facial appearance over time after facial filling
Time frame: Baseline, one, four and twelve 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 28 Nov 2022.
- Individual participant dataSharing planned: No. Results will be published in international medical journals
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.
Stig-Frederik T Kølle, MD, PhD principal investigator
Stemform
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ASC enriched lipofilling and Standard Lipofilling in people with Breast Hypoplasia and Facial Ageing, run by Stemform at 1 site in Denmark.
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 14 inclusion and 18 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 28 Nov 2022. 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 Denmark. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change in volume over time after breast augmentation (time frame: Baseline, four and twelve 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 28 Nov 2022.