AugmentationNCT05079243
Dermal and Subcutaneous Augmentation and Skin Assessment After Fat-, Stem Cell and Scaffold Injections
A study testing Scaffold and adipose-derived stromal cell enriched fat grafts in people with Augmentation and Reconstruction, run by Stemform at 2 sites in Denmark.
Trial summary
Investigate the effect of dermal/subcutaneous injection of ASC enriched fat transplant in a protective natural scaffold, designed to sustain the ASC viability after dermal/subcutaneous injection. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Augmentation, Reconstruction
- What is being tested?
- Scaffold and adipose-derived stromal cell enriched fat grafts
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesDenmark
- Study dates
- 4 Jun 2021to 1 Jun 2023
- Phase
- Interventional
- 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 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 18-30 kg/m2
- 400 mL of fat (lipoaspirate) available for liposuction in the thighs or back
- Desire for abdominoplasty
- Speaks and reads Danish
- Signed informed consent
Who cannot join
- Smoking
- Previous major abdominal surgery
- Previous cancer or predisposition to cancer
- Pregnancy or planned pregnancy
- Known chronic disease associated with metabolic malfunction or poor healing
- Pacemaker
- Allergy to necessary anaesthesia
- Intention of significant weight loss or weight gain within the trial period
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Aleris Hamlet
Copenhagen, Søborg, 2860
StemMedical
Copenhagen, Søborg, 2860
About this study
Official title: Examining the Best Solution for Dermal and Subcutaneous Augmentation and Regeneration Using Ex-vivo Expanded Autologous Adipose-derived Stromal Cells, Autologous Fat Tissue and Natural Tissue Scaffolds
Investigate the effect of dermal/subcutaneous injection of ASC enriched fat transplant in a protective natural scaffold, designed to sustain the ASC viability after dermal/subcutaneous injection.
Read the detailed description
The study investigates the effect of different concentrations of autologous ex-vivo expanded adipose-derived stromal cells (ASCs), fat and a natural scaffold for skin rejuvenation and augmentation. The aim is to better the volume of fat grafts for cosmetic and reconstructive purposes. Fat is a near ideal filler, as it is biocompatible. However the retention rate of fat grafts often result in poor outcomes and it is unpredictable. The investigators have set up an experimental study in which participants with excess abdominal skin is recruited. They will have injections with 11 different solutions of fat, ACSs, scaffold and dermal CO2 laser in the abdominal skin. After 3 months biopsies will be taken and after 6 months all of the treated area will be removed by an cosmetic abdominoplasty.
- Conditions
- Augmentation, Reconstruction
- Being tested
- Scaffold and adipose-derived stromal cell enriched fat grafts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaffold and adipose-derived stromal cell enriched fat graftsBiological
eight different solutions of fat, ASCs, scaffold and CO2 laser in dermis three different solutions of fat, ASCs and scaffold in the subcutaneous layer
| Study group | Role | What they receive |
|---|---|---|
| Scaffold and adipose-derived stromal cell enriched fat grafts | Experimental | Randomized and paired injections. Each participant will receive all 11 solutions. Receives: Biological: Scaffold and adipose-derived stromal cell enriched fat grafts |
| Controls samples | No intervention | Control samples of untreated skin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume assessment
CT scan
Measured: Baseline, three months, Six months
Secondary outcomes (3)
Cell count, immunohistochemistry, skin quality
Cell count, immunohistochemistry, skin quality
Measured: Three months, six months
Immunohistochemistry
Immunohistochemistry
Measured: Three months, six months
Skin thickness
Skin thickness
Measured: Three months, six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start4 Jun 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AugmentationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Triple blinded, randomized, paired study on healthy participants
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stemform
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Aleris-Hamlet Hospitaler København
- Responsible party
- Sponsor
- Investigators
- Frederik P Mamsen, Principal investigator, StemMedical A/Sstig-Frederik T Koelle, MD, PhD, Principal investigator, StemMedical A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079243
- Sponsor's protocol ID
- H-21004160
- Status last verified
- Nov 2022
- First submitted
- 6 Jun 2021
- Last updated
- 28 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon request IPD can be shared with different parties if assessed valid by the primary investigators
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
- Examining the Best Solution for Dermal and Subcutaneous Augmentation and Regeneration Using Ex-vivo Expanded Autologous Adipose-derived Stromal Cells, Autologous Fat Tissue and Natural Tissue Scaffolds
- ClinicalTrials.gov ID
- NCT05079243
- Acronym / sponsor ID
- H-21004160
- Conditions
- Augmentation, Reconstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (actual)
- Lead sponsor
- StemformIndustry (pharma, biotech, devices)
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Aleris-Hamlet Hospitaler København
- Study start
- 4 Jun 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 15 Oct 2021 (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.
Investigate the effect of dermal/subcutaneous injection of ASC enriched fat transplant in a protective natural scaffold, designed to sustain the ASC viability after dermal/subcutaneous injection.
Detailed description
The study investigates the effect of different concentrations of autologous ex-vivo expanded adipose-derived stromal cells (ASCs), fat and a natural scaffold for skin rejuvenation and augmentation. The aim is to better the volume of fat grafts for cosmetic and reconstructive purposes. Fat is a near ideal filler, as it is biocompatible. However the retention rate of fat grafts often result in poor outcomes and it is unpredictable. The investigators have set up an experimental study in which participants with excess abdominal skin is recruited. They will have injections with 11 different solutions of fat, ACSs, scaffold and dermal CO2 laser in the abdominal skin. After 3 months biopsies will be taken and after 6 months all of the treated area will be removed by an cosmetic abdominoplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Triple blinded, randomized, paired study on healthy participants
| Arm | Type | Receives |
|---|---|---|
| Scaffold and adipose-derived stromal cell enriched fat grafts | Experimental | Biological: Scaffold and adipose-derived stromal cell enriched fat graftsRandomized and paired injections. Each participant will receive all 11 solutions. |
| Controls samples | No intervention | –Control samples of untreated skin |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- BMI between 18-30 kg/m2
- 400 mL of fat (lipoaspirate) available for liposuction in the thighs or back
- Desire for abdominoplasty
- Speaks and reads Danish
- Signed informed consent
Key exclusion criteria (8 listed)
- Smoking
- Previous major abdominal surgery
- Previous cancer or predisposition to cancer
- Pregnancy or planned pregnancy
- Known chronic disease associated with metabolic malfunction or poor healing
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 |
|---|---|---|
| Scaffold and adipose-derived stromal cell enriched fat graftseight different solutions of fat, ASCs, scaffold and CO2 laser in dermis three different solutions of fat, ASCs and scaffold in the subcutaneous layer | Biological | Scaffold and adipose-derived stromal cell enriched fat grafts |
Primary outcome
Volume assessment
Time frame: Baseline, three months, Six months
CT scan
3 secondary outcomes
Cell count, immunohistochemistry, skin quality
Time frame: Three months, six months
Immunohistochemistry
Time frame: Three months, six months
Skin thickness
Time frame: Three months, six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2022.
- Individual participant dataSharing planned: No. Upon request IPD can be shared with different parties if assessed valid by the primary investigators
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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.
Frederik P Mamsen principal investigator
StemMedical A/S
stig-Frederik T Koelle, MD, PhD principal investigator
StemMedical A/S
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scaffold and adipose-derived stromal cell enriched fat grafts in people with Augmentation and Reconstruction, run by Stemform at 2 sites 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 5 inclusion and 8 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: status not confirmed, 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 2 sites 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.
Are results available for this study?
Results are not available in the source record.
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 assessment (time frame: Baseline, three months, Six 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.