A Phase 1/2 interventional study of Allogeneic adipose-Derived Mesenchymal Stromal Cells and Cryostor CS10 + Ringers Lactate in Scar Conditions and Fibrosis of Skin, Scar Quality Assessment and Safety and Scar Tissue, sponsored by Rigshospitalet, Denmark. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by Rigshospitalet, Denmark · Phase 1/2, Interventional, and Treatment
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.
611 studies on the registry are indexed under Cicatrix; 114 are open to participants now.
This study's planned enrollment of 39 is close to the median of 40 across 512 interventional studies indexed under Cicatrix.
Browse Cicatrix studies →Rigshospitalet, Denmark is the lead sponsor of 1,007 studies on the registry; 175 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Allogeneic adipose-Derived Mesenchymal Stromal Cells · Other: Cryostor CS10 + Ringers Lactate
Advanced therapeutic medicinal product
Placebo
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
Time frame: From enrollment to 12-month follow-up.
Change in Observer score of the Danish Patient and Observer Scar Assessment Scale version 3.0
The total score from all items, excluding the overall satisfaction
Time frame: From enrollment to 12-month follow-up.
Documentation of any adverse events (AEs), serious adverse advents (SAEs), and deaths.
All events will be documented and evaluated.
Time frame: From the day of intervention to 12-month follow-up.
Changes in scar volume and microstructure in nanocubic meters.
Measured by three-dimensional photography and software.
Time frame: From enrollment to 12-month follow-up.
Changes in scar elevation index/scar thickness as a ratio and in millimeters.
Measured by ultrasound video sequencing.
Time frame: From enrollment to 12-month follow-up.
Changes in collagen fiber arrangement.
Descriptive assessment of punch biopsies.
Time frame: From baseline biopsies to 12-month biopsies.
Up- or downregulation of fibrotic, inflammatory, and matrix remodeling biomarkers.
Advanced Nanostring technology.
Time frame: From baseline biopsies to 12-month biopsies.
The presence of donor stem cells/DNA
Descriptive assessment of punch biopsies.
Time frame: From punch biopsies at 12 months post-intervention.
Immune response/presence of donor-specific antibodies.
Evaluated by the development of de novo HLA.
Time frame: From baseline blood samples to six- and 12-month follow-up blood samples.
Plan to share: Yes — All IPD that underlies results in a publication will be shared.
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