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

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllCopenhagen University Hospital, Rigshospitalet
NCT07635875 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 out

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📋 Eligibility rules (as published)
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.
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What it tests

  • Allogeneic adipose-Derived Mesenchymal Stromal Cells
  • Cryostor CS10 + Ringers Lactate
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Where

1 site
Copenhagen University Hospital
Copenhagen, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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