Scar Conditions and Fibrosis of Skin, Scar Quality Assessment and Safety, Scar Tissue
Conditions
Keywords
Mesenchymal stromal cell therapy, Cell therapy, Regenerative medicine, Scar tissue, Clinical trial, ATMP
Brief summary
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
DRUGAllogeneic adipose-Derived Mesenchymal Stromal Cells
Advanced therapeutic medicinal product
OTHERCryostor CS10 + Ringers Lactate
Placebo
Sponsors
Rigshospitalet, Denmark
Odense University Hospital
University of Southern Denmark
Københavns Universitet
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model description
Within-participant randomized, triple-blinded study in which each participant receives both treatments (IMP and placebo) administered to two separate scar areas.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient score of the Danish Patient and Observer Scar Assessment Scale version 3.0 | From enrollment to 12-month follow-up. | The total score from all items, excluding the overall satisfaction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Observer score of the Danish Patient and Observer Scar Assessment Scale version 3.0 | From enrollment to 12-month follow-up. | The total score from all items, excluding the overall satisfaction |
| Documentation of any adverse events (AEs), serious adverse advents (SAEs), and deaths. | From the day of intervention to 12-month follow-up. | All events will be documented and evaluated. |
| Changes in scar volume and microstructure in nanocubic meters. | From enrollment to 12-month follow-up. | Measured by three-dimensional photography and software. |
| Changes in scar elevation index/scar thickness as a ratio and in millimeters. | From enrollment to 12-month follow-up. | Measured by ultrasound video sequencing. |
| Changes in collagen fiber arrangement. | From baseline biopsies to 12-month biopsies. | Descriptive assessment of punch biopsies. |
| Up- or downregulation of fibrotic, inflammatory, and matrix remodeling biomarkers. | From baseline biopsies to 12-month biopsies. | Advanced Nanostring technology. |
| The presence of donor stem cells/DNA | From punch biopsies at 12 months post-intervention. | Descriptive assessment of punch biopsies. |
| Immune response/presence of donor-specific antibodies. | From baseline blood samples to six- and 12-month follow-up blood samples. | Evaluated by the development of de novo HLA. |
Countries
Denmark
Contacts
CONTACTLaura Hansen, MD
Outcome results
None listed