2024-519160-41-00招募中2 期
Scar Remodeling after Burn Injury using Adipose-derived Allogeneic Stem Cells (ScarASC)
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Change in total patient score of the Danish Patient and Observer Scar Assessment Scale version 3.0.
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •Active cancer or previous cancer within two years (skin cancers do not apply).
- •Penicillin and Streptomycin allergy.
结局指标
主要结局
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.
次要结局
- 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 elevation index / scar thickness by ultrasound video sequencing, measured as a ratio and in milli meter.
- Changes in collagen fiber arrangement.
- Up- and/or downregulation of biomarkers from punch biopsies.
- Development of de novo HLA.
- 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.
研究者
Laura Hansen
Scientific
Copenhagen University Hospital
研究点 (1)
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