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Clinical Trials in Denmark / NCT07635875
Recruiting Phase 1/2

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

NCT07635875 · tracked via the Priya Life Science Denmark tracker
Sponsor
Copenhagen University Hospital, Rigshospitalet
Phase
Phase 1/2
Started
2026-04-16
Last updated
2026-06-09

Condition(s) studied

Scar Conditions and Fibrosis of SkinScar Quality Assessment and SafetyScar Tissue

Investigational drug(s) / intervention(s)

Allogeneic adipose-Derived Mesenchymal Stromal CellsCryostor CS10 + Ringers Lactate

Allogeneic adipose-Derived Mesenchymal Stromal Cells: Advanced therapeutic medicinal product

Cryostor CS10 + Ringers Lactate: Placebo

Study 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. 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Change in Patient score of the Danish Patient and Observer Scar Assessment Scale version 3.0 — From enrollment to 12-month follow-up.
    The total score from all items, excluding the overall satisfaction

Trial sites (1)

FacilityCityRegionStatus
Copenhagen University Hospital Copenhagen East Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07635875 on ClinicalTrials.gov ↗ ← All trials in Denmark