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

NCT07635875 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2026-06-09

No results posted yet for this 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.

Conditions

  • Scar Conditions and Fibrosis of Skin
  • Scar Quality Assessment and Safety
  • Scar Tissue

Interventions

DRUG

Allogeneic adipose-Derived Mesenchymal Stromal Cells

Advanced therapeutic medicinal product

OTHER

Cryostor CS10 + Ringers Lactate

Placebo

Sponsors & Collaborators

  • Odense University Hospital

    collaborator OTHER

  • University of Southern Denmark

    collaborator OTHER

  • Københavns Universitet

    collaborator OTHER

  • Rigshospitalet, Denmark

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-16
Primary Completion
2028-04-01
Completion
2028-05-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07635875 on ClinicalTrials.gov