Scar Remodeling After Burn Injury Using Allogeneic Adipose-derived Stromal Cells
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRigshospitalet, Denmark
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Allogeneic adipose-Derived Mesenchymal Stromal Cells
DrugAdvanced therapeutic medicinal product
Cryostor CS10 + Ringers Lactate
Other interventionPlacebo
Treatment groups
39 Participants
are divided into 1 treatment groupGroup A: All participantsOther 2 interventions
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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.2
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.3
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.4
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Rigshospitalet, Denmark
Lead sponsor
Odense University Hospital
Collaborator
University of Southern Denmark
Collaborator
Københavns Universitet
Collaborator
Source ClinicalTrials.gov