[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643757":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":40,"studyPopulation":40,"armGroups":49,"interventions":56,"overallOfficials":40,"centralContacts":66,"locations":72,"responsibleParty":89,"collaborators":93,"id":100,"slug":40,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":106,"sex":107,"minAge":108,"maxAge":40,"enrollmentInfo":109,"targetDuration":40,"studyType":112,"phases":113,"briefSummary":116,"conditions":117,"keywords":121,"overallStatus":75,"whyStopped":40,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":40},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Patient score of the Danish Patient and Observer Scar Assessment Scale version 3.0","The total score from all items, excluding the overall satisfaction","From enrollment to 12-month follow-up.",[14,16,20,23,26,30,33,36],{"measure":15,"description":11,"timeFrame":12},"Change in Observer score of the Danish Patient and Observer Scar Assessment Scale version 3.0",{"measure":17,"description":18,"timeFrame":19},"Documentation of any adverse events (AEs), serious adverse advents (SAEs), and deaths.","All events will be documented and evaluated.","From the day of intervention to 12-month follow-up.",{"measure":21,"description":22,"timeFrame":12},"Changes in scar volume and microstructure in nanocubic meters.","Measured by three-dimensional photography and software.",{"measure":24,"description":25,"timeFrame":12},"Changes in scar elevation index\u002Fscar thickness as a ratio and in millimeters.","Measured by ultrasound video sequencing.",{"measure":27,"description":28,"timeFrame":29},"Changes in collagen fiber arrangement.","Descriptive assessment of punch biopsies.","From baseline biopsies to 12-month biopsies.",{"measure":31,"description":32,"timeFrame":29},"Up- or downregulation of fibrotic, inflammatory, and matrix remodeling biomarkers.","Advanced Nanostring technology.",{"measure":34,"description":28,"timeFrame":35},"The presence of donor stem cells\u002FDNA","From punch biopsies at 12 months post-intervention.",{"measure":37,"description":38,"timeFrame":39},"Immune response\u002Fpresence of donor-specific antibodies.","Evaluated by the development of de novo HLA.","From baseline blood samples to six- and 12-month follow-up blood samples.",null,{"allocation":42,"interventionModel":43,"interventionModelDescription":44,"primaryPurpose":45,"observationalModel":40,"timePerspective":40,"maskingInfo":46},"NA","SINGLE_GROUP","Within-participant randomized, triple-blinded study in which each participant receives both treatments (IMP and placebo) administered to two separate scar areas.","TREATMENT",{"masking":47,"maskingDescription":48,"whoMasked":40},"NONE","Participants, care providers, investigators, and outcome assessors are all masked. All participants receive both treatments (IMP and placebo). However, the above-mentioned parties are blinded to which scar area will receive what treatment.",[50],{"label":51,"type":6,"description":52,"interventionNames":53},"All participants","All participants will receive both interventions (stromal cells (IMP) and placebo) in two separate scar areas. The treatments are masked and randomly allocated to the two scar areas.",[54,55],"Drug: Allogeneic adipose-Derived Mesenchymal Stromal Cells","Other: Cryostor CS10 + Ringers Lactate",[57,62],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":40},"DRUG","Allogeneic adipose-Derived Mesenchymal Stromal Cells","Advanced therapeutic medicinal product",[51],{"type":6,"name":63,"description":64,"armGroupLabels":65,"otherNames":40},"Cryostor CS10 + Ringers Lactate","Placebo",[51],[67],{"name":68,"role":69,"phone":70,"phoneExt":40,"email":71},"Laura Hansen, MD","CONTACT","+45 25330409","laura.hansen.01@regionh.dk",[73],{"facility":74,"status":75,"city":76,"state":77,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"Copenhagen University Hospital","RECRUITING","Copenhagen","East","2100","Denmark","DK",{"type":82,"coordinates":83},"Point",[84,85],12.56553,55.67594,{"lat":85,"lon":84},[88],{"name":68,"role":69,"phone":70,"phoneExt":40,"email":71},{"type":90,"investigatorFullName":91,"investigatorTitle":92,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"PRINCIPAL_INVESTIGATOR","Rikke Holmgaard","Medical doctor and Associate Professor",[94,96,98],{"name":95,"class":6},"Odense University Hospital",{"name":97,"class":6},"University of Southern Denmark",{"name":99,"class":6},"Københavns Universitet","100643757",false,"NCT07635875","Scar Remodeling After Burn Injury Using Allogeneic Adipose-derived Stromal Cells","ScarASC","Inclusion Criteria:\n\n* Adults ≥ 18 years of age\n* Males and females\n* Hypertrophic scars (age of scar \\> 2 years) after burn injuries on the front thorax or extremities.\n* 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.\n* Ability to understand information about the project.\n\nExclusion Criteria:\n\n* Significant comorbidities or lack of cognitive abilities to follow instructions.\n* Not being able to participate due to language or other personal issues.\n* Pregnancy or breastfeeding\n* Current or previous steroid therapy (systemic or local) within one year.\n* Scar revision surgery within one year in the affected areas.\n* Keloids.\n* Active cancer or previous cancer within two years (skin cancers do not apply)\n* Penicillin and Streptomycin allergy.",true,"ALL","18 Years",{"count":110,"type":111},39,"ESTIMATED","INTERVENTIONAL",[114,115],"PHASE1","PHASE2","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\u002Fprotein expression regulation.",[118,119,120],"Scar Conditions and Fibrosis of Skin","Scar Quality Assessment and Safety","Scar Tissue",[122,123,124,125,126,127],"Mesenchymal stromal cell therapy","Cell therapy","Regenerative medicine","Scar tissue","Clinical trial","ATMP","2026-06-03",{"date":130,"type":131},"2026-06-09","ACTUAL",{"date":133,"type":131},"2026-04-16",{"date":135,"type":111},"2028-05-31",{"name":5,"class":6},1]