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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-519160-41-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Odense University Hospital | OTHER |
| University of Southern Denmark | OTHER |
| Københavns Universitet | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic adipose-Derived Mesenchymal Stromal Cells | Drug | Advanced therapeutic medicinal product |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From enrollment to 12-month follow-up. |
| Documentation of any adverse events (AEs), serious adverse advents (SAEs), and deaths. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Hansen, MD | Contact | +45 25330409 | laura.hansen.01@regionh.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital | Recruiting | Copenhagen | East | 2100 | Denmark |
All IPD that underlies results in a publication will be shared.
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Within-participant randomized, triple-blinded study in which each participant receives both treatments (IMP and placebo) administered to two separate scar areas.
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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.
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| Cryostor CS10 + Ringers Lactate | Other | Placebo |
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All events will be documented and evaluated. |
| 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. | 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. | From enrollment to 12-month follow-up. |
| Changes in collagen fiber arrangement. | Descriptive assessment of punch biopsies. | From baseline biopsies to 12-month biopsies. |
| Up- or downregulation of fibrotic, inflammatory, and matrix remodeling biomarkers. | Advanced Nanostring technology. | From baseline biopsies to 12-month biopsies. |
| The presence of donor stem cells/DNA | Descriptive assessment of punch biopsies. | From punch biopsies at 12 months post-intervention. |
| Immune response/presence 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. |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077325 | Ringer's Lactate |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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