Scar Remodeling After Burn Injury Using Allogeneic Adipose-derived Stromal Cells (ScarASC)

June 3, 2026 updated by: Rikke Holmgaard, Rigshospitalet, Denmark
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

39

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
    • East
      • Copenhagen, East, Denmark, 2100
        • Recruiting
        • Copenhagen University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: All participants
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.
Drug: Allogeneic adipose-Derived Mesenchymal Stromal Cells
Advanced therapeutic medicinal product
Other: Cryostor CS10 + Ringers Lactate
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment to 12-month follow-up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The total score from all items, excluding the overall satisfaction
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.
All events will be documented and evaluated.
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.
Measured by three-dimensional photography and software.
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.
Measured by ultrasound video sequencing.
From enrollment to 12-month follow-up.
Changes in collagen fiber arrangement.
Time Frame: From baseline biopsies to 12-month biopsies.
Descriptive assessment of punch biopsies.
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.
Advanced Nanostring technology.
From baseline biopsies to 12-month biopsies.
The presence of donor stem cells/DNA
Time Frame: From punch biopsies at 12 months post-intervention.
Descriptive assessment of punch biopsies.
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.
Evaluated by the development of de novo HLA.
From baseline blood samples to six- and 12-month follow-up blood samples.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

Odense University Hospital
University of Southern Denmark
Københavns Universitet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

May 31, 2028

Study Registration Dates

First Submitted

June 3, 2026

First Submitted That Met QC Criteria

June 3, 2026

First Posted (Actual)

June 9, 2026

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ScarASC
  • 2024-519160-41-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlies results in a publication will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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