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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Advanced therapeutic medicinal product
Placebo
Copenhagen University Hospital
Copenhagen, East, Denmark
RECRUITINGChange 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.
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