Scar Conditions and Fibrosis of SkinPhase 1/2ScarASCNCT07635875
Scar Remodeling After Burn Injury Using Allogeneic Adipose-derived Stromal Cells
A Phase 1/2 study testing Allogeneic adipose-Derived Mesenchymal Stromal Cells and Cryostor CS10 + Ringers Lactate in people with Scar Conditions and Fibrosis of Skin and Scar Quality Assessment and Safety, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The present project serves to test whether stem cell therapy offers a new treatment option for the scars of burn survivors. In Denmark, 12.000 people seek medical assistance every year for burn injuries leaving thousands of people with the devastating condition of hypertrophic scarring. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Scar Conditions and Fibrosis of Skin, Scar Quality Assessment and Safety, Scar Tissue
- What is being tested?
- Allogeneic adipose-Derived Mesenchymal Stromal Cells and Cryostor CS10 + Ringers Lactate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteDenmark
- Study dates
- 16 Apr 2026to 31 May 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years of age
- Males and females
- Hypertrophic scars (age of scar > 2 years) after burn injuries on the front thorax or extremities.
- Two uniform 6 cm x 6 cm areas of burn scar tissue on the front thorax or extremities. The scar should be large enough to separate the areas by a minimum of two centimeters.
- Ability to understand information about the project.
Who cannot join
- Significant comorbidities or lack of cognitive abilities to follow instructions.
- Not being able to participate due to language or other personal issues.
- Pregnancy or breastfeeding
- Current or previous steroid therapy (systemic or local) within one year.
- Scar revision surgery within one year in the affected areas.
- Keloids.
- Active cancer or previous cancer within two years (skin cancers do not apply)
- Penicillin and Streptomycin allergy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital
Copenhagen, East, 2100
Laura Hansen, MD, +45 25330409, laura.hansen.01@regionh.dk
About this study
The present project serves to test whether stem cell therapy offers a new treatment option for the scars of burn survivors. In Denmark, 12.000 people seek medical assistance every year for burn injuries leaving thousands of people with the devastating condition of hypertrophic scarring. Affected patients experience pain, itching, numbness, and reduced range of motion, which profoundly impact their quality of life. We hypothesize that adipose-derived stem cells can improve scar quality. To test this, we have conducted an integrated phase I + II trial (the ScarASC trials). ScarASC will be the first randomized controlled trial to use stem cells in burn patients. Two scar areas in each patient will be randomly injected with A) allogeneic adipose-derived stem cells and B) the control medium (placebo). We maintain a patient-centered scope, with our primary endpoint being a patient-reported outcome measure. However, we also obtain objective scar assessments using three-dimensional photographs, the scar elevation index, and gene/protein expression regulation.
- Being tested
- Allogeneic adipose-Derived Mesenchymal Stromal Cells, Cryostor CS10 + Ringers Lactate
- Keywords
- Mesenchymal stromal cell therapy, Cell therapy, Regenerative medicine, Scar tissue, Clinical trial, ATMP
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic adipose-Derived Mesenchymal Stromal CellsDrug
Advanced therapeutic medicinal product
Cryostor CS10 + Ringers LactateOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| All participants | Other | All participants will receive both interventions (stromal cells (IMP) and placebo) in two separate scar areas. The treatments are masked and randomly allocated to the two scar areas. Receives: Drug: Allogeneic adipose-Derived Mesenchymal Stromal Cells; Other: Cryostor CS10 + Ringers Lactate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient score of the Danish Patient and Observer Scar Assessment Scale version 3.0
The total score from all items, excluding the overall satisfaction
Measured: From enrollment to 12-month follow-up.
Secondary outcomes (8)
Change in Observer score of the Danish Patient and Observer Scar Assessment Scale version 3.0
The total score from all items, excluding the overall satisfaction
Measured: From enrollment to 12-month follow-up.
Documentation of any adverse events (AEs), serious adverse advents (SAEs), and deaths.
All events will be documented and evaluated.
Measured: From the day of intervention to 12-month follow-up.
Changes in scar volume and microstructure in nanocubic meters.
Measured by three-dimensional photography and software.
Measured: From enrollment to 12-month follow-up.
Changes in scar elevation index/scar thickness as a ratio and in millimeters.
Measured by ultrasound video sequencing.
Measured: From enrollment to 12-month follow-up.
Changes in collagen fiber arrangement.
Descriptive assessment of punch biopsies.
Measured: From baseline biopsies to 12-month biopsies.
Up- or downregulation of fibrotic, inflammatory, and matrix remodeling biomarkers.
Advanced Nanostring technology.
Measured: From baseline biopsies to 12-month biopsies.
The presence of donor stem cells/DNA
Descriptive assessment of punch biopsies.
Measured: From punch biopsies at 12 months post-intervention.
Immune response/presence of donor-specific antibodies.
Evaluated by the development of de novo HLA.
Measured: From baseline blood samples to six- and 12-month follow-up blood samples.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start16 Apr 2026
- Primary completion1 Apr 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scar Conditions and Fibrosis of SkinStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Within-participant randomized, triple-blinded study in which each participant receives both treatments (IMP and placebo) administered to two separate scar areas.
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, University of Southern Denmark, Københavns Universitet
- Responsible party
- Principal investigator, Rikke Holmgaard, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07635875
- Sponsor's protocol ID
- ScarASC
- Other IDs
- 2024-519160-41-00
- Acronym
- ScarASC
- Status last verified
- May 2026
- First submitted
- 3 Jun 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlies results in a publication will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scar Remodeling After Burn Injury Using Allogeneic Adipose-derived Stromal Cells
- ClinicalTrials.gov ID
- NCT07635875
- Acronym / sponsor ID
- ScarASC / ScarASC
- Keywords
- Mesenchymal stromal cell therapy, Cell therapy, Regenerative medicine, Scar tissue, Clinical trial, ATMP
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Odense University Hospital, University of Southern Denmark, Københavns Universitet
- Study start
- 16 Apr 2026 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 9 Jun 2026 (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 present project serves to test whether stem cell therapy offers a new treatment option for the scars of burn survivors. In Denmark, 12.000 people seek medical assistance every year for burn injuries leaving thousands of people with the devastating condition of hypertrophic scarring. Affected patients experience pain, itching, numbness, and reduced range of motion, which profoundly impact their quality of life. We hypothesize that adipose-derived stem cells can improve scar quality. To test this, we have conducted an integrated phase I + II trial (the ScarASC trials). ScarASC will be the first randomized controlled trial to use stem cells in burn patients. Two scar areas in each patient will be randomly injected with A) allogeneic adipose-derived stem cells and B) the control medium (placebo). We maintain a patient-centered scope, with our primary endpoint being a patient-reported outcome measure. However, we also obtain objective scar assessments using three-dimensional photographs, the scar elevation index, and gene/protein expression regulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Within-participant randomized, triple-blinded study in which each participant receives both treatments (IMP and placebo) administered to two separate scar areas.
| Arm | Type | Receives |
|---|---|---|
| All participants | Other | Drug: Allogeneic adipose-Derived Mesenchymal Stromal Cells, Other: Cryostor CS10 + Ringers LactateAll participants will receive both interventions (stromal cells (IMP) and placebo) in two separate scar areas. The treatments are masked and randomly allocated to the two scar areas. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults ≥ 18 years of age
- Males and females
- Hypertrophic scars (age of scar > 2 years) after burn injuries on the front thorax or extremities.
- Two uniform 6 cm x 6 cm areas of burn scar tissue on the front thorax or extremities. The scar should be large enough to separate the areas by a minimum of two centimeters.
- Ability to understand information about the project.
Key exclusion criteria (8 listed)
- Significant comorbidities or lack of cognitive abilities to follow instructions.
- Not being able to participate due to language or other personal issues.
- Pregnancy or breastfeeding
- Current or previous steroid therapy (systemic or local) within one year.
- Scar revision surgery within one year in the affected areas.
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 |
|---|---|---|
| Allogeneic adipose-Derived Mesenchymal Stromal CellsAdvanced therapeutic medicinal product | Drug | All participants |
| Cryostor CS10 + Ringers LactatePlacebo | Other | All participants |
Primary outcome
Change in Patient score of the Danish Patient and Observer Scar Assessment Scale version 3.0
Time frame: From enrollment to 12-month follow-up.
The total score from all items, excluding the overall satisfaction
8 secondary outcomes
Change in Observer score of the Danish Patient and Observer Scar Assessment Scale version 3.0
Time frame: From enrollment to 12-month follow-up.
Documentation of any adverse events (AEs), serious adverse advents (SAEs), and deaths.
Time frame: From the day of intervention to 12-month follow-up.
Changes in scar volume and microstructure in nanocubic meters.
Time frame: From enrollment to 12-month follow-up.
Changes in scar elevation index/scar thickness as a ratio and in millimeters.
Time frame: From enrollment to 12-month follow-up.
Changes in collagen fiber arrangement.
Time frame: From baseline biopsies to 12-month biopsies.
Up- or downregulation of fibrotic, inflammatory, and matrix remodeling biomarkers.
Time frame: From baseline biopsies to 12-month biopsies.
The presence of donor stem cells/DNA
Time frame: From punch biopsies at 12 months post-intervention.
Immune response/presence of donor-specific antibodies.
Time frame: From baseline blood samples to six- and 12-month follow-up blood samples.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlies results in a publication will be shared.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Allogeneic adipose-Derived Mesenchymal Stromal Cells and Cryostor CS10 + Ringers Lactate in people with Scar Conditions and Fibrosis of Skin and Scar Quality Assessment and Safety, run by Copenhagen University Hospital, Rigshospitalet 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 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: looking for participants now, as of the sponsor's last update on 9 Jun 2026. 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 combined 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.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Hansen, MD (+45 25330409, laura.hansen.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient score of the Danish Patient and Observer Scar Assessment Scale version 3.0 (time frame: From enrollment to 12-month follow-up.). 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 9 Jun 2026.