Scar Remodeling After Burn Injury Using Allogeneic Adipose-derived Stromal Cells
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Allogeneic adipose-Derived Mesenchymal Stromal Cells, Cryostor CS10 + Ringers Lactate.
- Who it may be relevant to
- Registry conditions: Scar Conditions and Fibrosis of Skin, Scar Quality Assessment and Safety, Scar Tissue. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Allogeneic adipose-Derived Mesenchymal Stromal Cells
Advanced therapeutic medicinal product - Other Cryostor CS10 + Ringers Lactate
Placebo
Primary outcome measures
- Change in Patient score of the Danish Patient and Observer Scar Assessment Scale version 3.0 [Time frame: From enrollment to 12-month follow-up.]
Secondary outcome measures (8)
- Change in Observer score of the Danish Patient and Observer Scar Assessment Scale version 3.0 [Time frame: From enrollment to 12-month follow-up.]
- Documentation of any adverse events (AEs), serious adverse advents (SAEs), and deaths. [Time frame: From the day of intervention to 12-month follow-up.]
- Changes in scar volume and microstructure in nanocubic meters. [Time frame: From enrollment to 12-month follow-up.]
- Changes in scar elevation index/scar thickness as a ratio and in millimeters. [Time frame: From enrollment to 12-month follow-up.]
- Changes in collagen fiber arrangement. [Time frame: From baseline biopsies to 12-month biopsies.]
- Up- or downregulation of fibrotic, inflammatory, and matrix remodeling biomarkers. [Time frame: From baseline biopsies to 12-month biopsies.]
- The presence of donor stem cells/DNA [Time frame: From punch biopsies at 12 months post-intervention.]
- Immune response/presence of donor-specific antibodies. [Time frame: From baseline blood samples to six- and 12-month follow-up blood samples.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Copenhagen University Hospital — Copenhagen
Identifiers
NCT: NCT07635875 · ScarASC · 2024-519160-41-00