Transplantation of Bone Marrow Mesenchymal Stem Cell in Moderate to Severe Fistulizing Crohn's Disease
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- fistula closure
研究概览
简要总结
This study is a prospective, randomized, parallel, phase 1 trial to assess the safety and feasibility of the transplantation of bone marrow derived mesenchymal stem cells (MSCs) in fistulizing Crohn's disease.
详细描述
In this study all eligible patients were randomly allocated into two study groups by a permuted block randomization method: group A receives only autologous MSCs suspended in fibrin glue, group B receives autologous MSCs+ Fibroblasts. Both groups receive 4 injections inside the wall and lumen of the fistula. Injections will be repeated every month.
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
- Single (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
- •1- Poor response to routine treatments in refractory Crohn's disease with fistula.
- •2- CDAI>220 3- Age 18 to 60 years 4- GFR>30, Cr<2 5- The presence of perinea fistula.
排除标准
- •pregnancy
研究组 & 干预措施
mesenchymal cell and fibroblast transplantaion
The patients with crohn's disease who underwent mesenchymal cell and fibroblast injection.
干预措施: mesenchymal cell and fibroblast injection (Biological)
mesenchymal cell transplantaion
The patients with Crohn's disease who underwent mesenchymal cell transplantation.
干预措施: mesenchymal cell transplantation (Biological)
结局指标
主要结局
fistula closure
时间窗: 4months
Evaluation the fistula closure after mesenchymal cell transplantation in patients with crohn's disease.
次要结局
- CDAI(4months)