NCT01221428Unknown1 期
Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative Colitis
Qingdao University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年9月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- the result of enteroscopy and pathological report
研究概览
简要总结
The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of treatment for ulcerative colitis is safe and effective.
详细描述
Ulcerative colitis is characterized as chronic and nonspecific inflammation of gastroenteritis tract．Nowadays，etiology and pathogenesis of UC have been unclear．Recent basic research has been revealed that stem cell can settle down in epithelium of gastroenteritis tract，which provide a hope for treating the disease.We hope umbilical cord Mesenchymal Stem Cells could not only address the need for epithelial cell replacement but also control of the autoimmune response to mocous membrane of colon.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 years of age or older.
- •Ulcerative colitis described according to usual criteria.
- •Refractoriness Ulcerative colitis or unefficient by using other therapy
- •Signed informed consent form.
排除标准
- •History of neoplasm or hematological disease
- •Uncontrolled high blood pressure (>180/110)
- •Severe cardiac insufficiency (New York Heart Association [NYHA] IV) or ejection fraction<30%
- •Malignant ventricular arrythmia
- •Deep venous thrombosis during the last 3 months
- •Active bacterial infection
- •Body mass index > 35 Kg/m2
- •Stroke or myocardial infarction during the last 3 months
结局指标
主要结局
the result of enteroscopy and pathological report
时间窗: 3 months
次要结局
- the clinical symptom (including stomachache,abdominal distention,bloody purulent stool)(3 months)
研究者
研究点 (1)
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