The Safety and Efficiacy of Local MSC Injection in the Treatment of Fistulas in Patients With Perianal 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(fistula closure)
研究概览
简要总结
Here investigators will carry out this phase II clinical trial to explore a effective therapeutic regimen of MSC in the Crohn's perianal fistula.
详细描述
Peri-anal fistula is common seen in Crohn's disease. Treatments including surgery, antibiotics, immunosuppressive drug and infliximab improve the quality of life of the patients suffering Crohn's perianal fistula, but the recurrent rate is still high. MSC showed promising effect in the therapy of CD, but the standard treatment strategy is unclear. Here investigators will carry out this phase II clinical trial to explore a effective therapeutic regimen of MSC in the Crohn's perianal fistula.
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
- •Age 18-65 years old, male or female;
- •refractory CD fistula, there are 1-2 and 1-3 in the mouth fistula;
- •Diagnostic CD at least three months;
- •CDAI <250;
- •were receiving drug treatment (5-ASA and hormones> 4 weeks, immunosuppressants and biological agents> 8 weeks);
- •signed informed consent.
排除标准
- •with intestinal obstruction, stenosis, or perianal abscess;
- •pregnant or lactating women;
- •infection needs antibiotics persons;
- •rectovaginal fistula;
- •complex anal fistula more than two inside the mouth;
- •stenosis or perforation CD;
- •perianal infection;
- •could not do rectal or anal stenosis local injection therapy;
- •with acute enteritis;
- •, liver and kidney dysfunction;
- •a month have used other drugs are in clinical trials;
- •no conditions or unwilling to carry out MRI inspected;
- •who are adjusting therapy;
- •HIV patients;
- •The combined active hepatitis or tuberculosis; Occurred in 16) 6 months opportunistic infections, or severe infections occur within three months;
- •In the past five years, those who suffer from cancer; 18) there is a history of lymphoproliferative disease.
结局指标
主要结局
Clinical response(fistula closure)
时间窗: 12 weeks
Physical examination indicates fistula healing, or MRI examinations showed fistula healing more than 2cm
次要结局
- C-reactive protein (CRP)(12 weeks)
- Clinical Response(6 weeks after receiving treatment)