Evaluation of the Safety and Effectiveness of Mesenchymal Stem Cell Conditioned Medium-derived Pleiotropic Factor in Treating Residual Burn Wound
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- wound healing rate
研究概览
简要总结
Treatment of extensive deep burn residual wounds is a common problem in burn plastic surgery. Due to bacterial invasion, excessive maturation of granulation tissue, poor abrasion resistance of new epithelium, and coexistence of wound healing and dissolution can lead to delayed wound healing. Residual wounds rarely heal spontaneously and are prone to recurrence. Mesenchymal stem cells (MSC) boost tissue repair through paracrine. Many biological effectors, including IGF-1, vascular endothelial growth factor (VEGF), TGF-β1 have been found in MSC conditioned media (MSC-CM), and play a role in promoting tissue repair and regeneration.Our previous animal experiments have confirmed the role of MSC-CM in regulating wound inflammation, repairing damaged repair cells and promoting wound regeneration. In here, we will evaluate the safety and effectiveness of mesenchymal stem cell conditioned medium-derived pleiotropic factor in treating residual burn wound.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with thermal burns are all residual wounds that have not healed after 1 month; The distance between adjacent residual wounds of the same patient is greater than 10cm; Patients signing informed consent -
排除标准
- •Patients with severe heart, lung, liver, kidney, blood and mental system diseases; Combined with diabetes, hypertension and malnutrition; Patients with shock, severe systemic infections, and pregnant or lactating women. -
结局指标
主要结局
wound healing rate
时间窗: 2 months
Original wound area minus unhealed wound area divided by original wound area
次要结局
未报告次要终点
研究者
Xiaobing Fu
Professor
Chinese PLA General Hospital