Clinical Study of Umbilical Cord Blood Mononuclear Cells (UCB-MNCs) in Promoting Traumatic Fracture Healing
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Bone defect connection
研究概览
简要总结
The aim of this study is to explore the effectiveness and safety of umbilical cord blood mononuclear cells in promoting traumatic fracture healing.
详细描述
Umbilical cord blood mononuclear cells are a type of cell group containing hematopoietic stem cells, mesenchymal stem cells, neural stem cells, endothelial cells, immune cells, etc.In this study ,umbilical cord blood mononuclear cells will be used in promoting traumatic fracture healing,and the effectiveness and safety of the treatment plan was evaluated by twelve months of follow-up after treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Traumatic long bone fracture.
- •Noninfectious bone nonunion, delayed bone union.
- •3 months after the operation of the fracture, the examination showed no callus growth, no signs of progressive repair at the fracture site, fracture piece space < 5mm.
- •No shortening, angulation and displacement.
- •There was no obvious callus growth 8 months after local bone grafting.
排除标准
- •There are infection foci at and near the fracture end after fracture.
- •3 months after the fracture, tests showed partial callus growth.
- •Combining shortening, angulation and displacement phenomena.
- •Partial callus grew 8 months after local bone grafting.
研究组 & 干预措施
Umbilical cord blood mononuclear cells group
Umbilical cord blood mononuclear cells (cell number 1×108/2mL), once every two weeks, 3 times in total.
干预措施: Umbilical cord blood mononuclear cells (Biological)
Staphylococcal Enterotoxin C group
Staphylococcal enterotoxin C (2mL), once every two weeks, 3 times in total.
干预措施: Staphylococcal Enterotoxin C (Drug)
结局指标
主要结局
Bone defect connection
时间窗: 1 month to 1 year after treatment
0 points for complete fracture lines, 2 points for partial fracture lines, 4 points for lack of fracture lines.
Bone formation
时间窗: 1 month to 1 year after treatment
If there is no bone formation, 0 points. Bone formation accounts for 25% of the fracture area, 1 point. Bone formation accounts for 50% of the fracture area, 2 points. Bone formation accounts for 75% of the fracture area, 3 points. Bone filled the gap between fracture ends, 4 points.
Bone reconstruction
时间窗: 1 month to 1 year after treatment
0 points for no manifestations of reconstruction,2 points for intramedullary cavity can be reconstructed , and 4 points for the cortical bone can be completely reconstructed. A total score of 11 points or more achieves a good healing effect.
次要结局
未报告次要终点
研究者
Lili Cao
Professor
Qianfoshan Hospital