RecruitingPhase 1Phase 2NCT07635875

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


Sponsor

Rigshospitalet, Denmark

Enrollment

39 participants

Start Date

Apr 16, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Allogeneic adipose-Derived Mesenchymal Stromal Cells and Cryostor CS10 + Ringers Lactate for people with scar conditions and fibrosis of skin, scar quality assessment and safety, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAllogeneic adipose-Derived Mesenchymal Stromal Cells

Advanced therapeutic medicinal product

OTHERCryostor CS10 + Ringers Lactate

Placebo


Locations(1)

Copenhagen University Hospital

Copenhagen, East, Denmark

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NCT07635875