Evaluation the Safety and Efficacy of Allogeneic Mesenchymal Stem Cell Transplantation in Tibial Closed Diaphyseal Fractures
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of patients with union after transplantation of mesenchymal stem cell in case group in comparison with control group
研究概览
简要总结
This study is a case-control prospective, clinal trial to assess the safety and efficacy of the allogeneic adipose derived mesenchymal stem cell transplantation on the healing of recent tibial fracture in 40 patients.
详细描述
In this study all eligible patients divided in 2 group.20 patients received allogeneic adipose derived mesenchymal stem cell in the fractured site (case group) and other patients received the placebo in the fractured site (control group) .
To assess the outcomes, we will evaluate the patients at 2, 6 weeks and 3, 6 months after transplantation by: X-ray, BMD , VAS and biochemical analysis with laboratory tests.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 65 years
- •The presence of tibial fracture based on X ray
- •tibial fracture is limited to diaphysial
排除标准
- •Addiction
- •Pregnancy
- •liver or kidney disease or uncontrolled diabetes or heart and lung disease
- •immune deficiency
结局指标
主要结局
Number of patients with union after transplantation of mesenchymal stem cell in case group in comparison with control group
时间窗: 6 months
次要结局
未报告次要终点