Scar Remodeling After Burn Injury Using Allogeneic Adipose-derived Stromal Cells
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 39
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
- •Active cancer or previous cancer within two years (skin cancers do not apply)
- •Penicillin and Streptomycin allergy.
研究者
Rikke Holmgaard
Medical doctor and Associate Professor
Rigshospitalet, Denmark