A Stage II Clinical Trial Comparing the Efficiacy of Routine Treatment Combined With or Without MSC Therapy in Refractory Crohn's Disease
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 3
- 主要终点
- Clinical Response of CD patients 12 weeks after receiving treatment (Reduction of CDAI score at less 100)
研究概览
简要总结
The investigators' preliminary study indicates that MSC is effective therapy in treating IBD. But the standard treatment is still lacking and the effect is not stable in IBD patients. This study is to explore the efficacy and standard strategy when using MSC in refractory IBD.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Failure or intolerance to GC, immune inhibitors and biological agents treatment
- •CDAI between 250-450
- •Weight between 40-150 kg
- •Normal renal function
- •endoscopic or imaging diagnosis of CD in the small intestine, colon ileocolon
- •Signed informed consent
排除标准
- •HIV or active hepatitis patients;
- •Allergic to CT contrast agents, cattle or pig products;
- •Stricture or perforation type CD;
- •Recieved permanent colostomy;
- •Used biological preparation in 3 months
- •Used prednisone > 20 mg/day within 1 month ;
- •Patients with short bowel syndrome;
- •Need total parenteral nutrition;
- •Liver meritorious service is abnormal;
- •Suffering from malignant tumor during the last 5 years;
- •Combined bacterial or viral enteritis;
- •Suffering from intestinal typicality thickening of the living
- •Patients with tuberculosis.
研究组 & 干预措施
MSC-1
Patients in this arms receive routine treatment with 3×10E6/kg of MSC
干预措施: Routine Treatment of CD (Drug)
MSC-1
Patients in this arms receive routine treatment with 3×10E6/kg of MSC
干预措施: MSC treatment 01 (Biological)
MSC-2
Patients in this arms receive routine treatment with 6×10E6/kg of MSC
干预措施: Routine Treatment of CD (Drug)
MSC-2
Patients in this arms receive routine treatment with 6×10E6/kg of MSC
干预措施: MSC treatment 02 (Biological)
Ctrl
Patients in this arms receive routine treatment with NS injection
干预措施: Routine Treatment of CD (Drug)
Ctrl
Patients in this arms receive routine treatment with NS injection
干预措施: NS (Other)
结局指标
主要结局
Clinical Response of CD patients 12 weeks after receiving treatment (Reduction of CDAI score at less 100)
时间窗: 12 weeks after receiving treatment
Reduction of CDAI score at less 100
次要结局
- Clinical Response of CD patients 6 weeks after receiving treatment (CDAI score less than 150)(6 weeks after receiving treatment)