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NCT Number: NCT07635875

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

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.

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Key information

Conditions

Scar Conditions and Fibrosis of Skin Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Scar Quality Assessment and Safety Scar Tissue

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Copenhagen University Hospital

Copenhagen, East, 2100, Denmark

Location status: Recruiting

Location contact

Laura Hansen, MD

CONTACT

[email protected]

+45 25330409

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Allogeneic adipose-Derived Mesenchymal Stromal Cells

Drug

Advanced therapeutic medicinal product

Cryostor CS10 + Ringers Lactate

Other

Placebo

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. Changes in collagen fiber arrangement.

    Time frame: From baseline biopsies to 12-month biopsies.

    Descriptive assessment of punch biopsies.

  6. Up- or downregulation of fibrotic, inflammatory, and matrix remodeling biomarkers.

    Time frame: From baseline biopsies to 12-month biopsies.

    Advanced Nanostring technology.

  7. The presence of donor stem cells/DNA

    Time frame: From punch biopsies at 12 months post-intervention.

    Descriptive assessment of punch biopsies.

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Hansen, MD

CONTACT

[email protected]

+45 25330409

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Københavns Universitet
  • Odense University Hospital
  • University of Southern Denmark

Registry information

Acronym: ScarASC

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 9, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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