Scar Remodeling after Burn Injury using Adipose-derived Allogeneic Stem Cells
- Conditions
- Hypertrophic scarring.
- Registration Number
- 2024-519160-41-00
- Lead Sponsor
- Copenhagen University Hospital
- Brief Summary
The objective is to investigate the potential therapeutic efficacy of allogeneic adipose-derived stem cells and autologous stromal vascular fraction on scar quality as compared to placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised, recruitment pending
- Sex
- Not specified
- Target Recruitment
- 39
Adults ≥ 18 years of age
Hypertrophic scars (age of scar > 2 years) after burn injuries on the front trunk or extremities.
Three uniform 6 cm x 6 cm areas of burn scar tissue on the front of the thorax or extremities. The scar should be large enough to separate the areas with a minimum of two centimeters.
BMI > 22 and enough abdominal fat for a minor liposuction.
Ability to understand information about the project.
Significant comorbidities or lack of cognitive abilities to follow instructions.
Tobacco smoking.
Not being able to participate due to language or other personal issues.
Contraindications for abdominal liposuction.
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.
Study & Design
- Study Type
- Not specified
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in total patient score of the Danish Patient and Observer Scar Assessment Scale version 3.0. Change in total patient score of the Danish Patient and Observer Scar Assessment Scale version 3.0.
- Secondary Outcome Measures
Name Time Method Change in total observer score of the Danish Patient and Observer Scar Assessment Scale version 3.0. Change in total observer score of the Danish Patient and Observer Scar Assessment Scale version 3.0.
Scar volume and microstructure measured by three-dimensional photography, measured in nano cubic meter. Scar volume and microstructure measured by three-dimensional photography, measured in nano cubic meter.
Scar elevation index / scar thickness by ultrasound video sequencing, measured as a ratio and in milli meter. Scar elevation index / scar thickness by ultrasound video sequencing, measured as a ratio and in milli meter.
Changes in collagen fiber arrangement. Changes in collagen fiber arrangement.
Up- and/or downregulation of biomarkers from punch biopsies. Up- and/or downregulation of biomarkers from punch biopsies.
Development of de novo HLA. Development of de novo HLA.
Histologic assessment of the presence of donor stem cells / DNA. Histologic assessment of the presence of donor stem cells / DNA.
Safety assessment by documenting any adverse events or suspected unexpected serious adverse reactions at every follow-up. Safety assessment by documenting any adverse events or suspected unexpected serious adverse reactions at every follow-up.
Trial Locations
- Locations (1)
Rigshospitalet
🇩🇰Copenhagen Oe, Denmark
Rigshospitalet🇩🇰Copenhagen Oe, DenmarkRikke HolmgaardSite contact+4535451779Rikke.holmgaard@regionh.dk