Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Crohn's disease activity index
研究概览
简要总结
Stem cell transplantation has emerged as a relatively popular treatment that can help to regulate immunity, repair injury, and control inflammation. Several studies have used autologous stem cells or adipose-derived stem cells to treat Crohn's disease and its associated complications, and have achieved good efficacy. Thus far, the use of umbilical cord mesenchymal stem cells (UC-MSCs) to treat Crohn's disease has rarely been reported. In this study, UC-MSCs were used to treat patients with hormone-controlled Crohn's disease. We observed the disease control conditions, corticosteroid dosage changes, and treatment-related adverse reactions.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •above 18 years of age
- •moderate to severe Crohn's disease (Crohn's disease activity index (CDAI) between 220 and 450)
- •had received hormone maintenance therapy for more than 6 months
排除标准
- •active tuberculosis
- •malignancy
- •hepatitis B
- •hepatitis C
研究组 & 干预措施
UC-MSCs
UC-MSCs by peripheral intravenous infusion
干预措施: UC-MSCs by peripheral intravenous infusion (Other)
control
received hormone maintenance therapy
干预措施: received hormone maintenance therapy (Drug)
结局指标
主要结局
Crohn's disease activity index
时间窗: 12 months
次要结局
- Harvey-Bradshaw index(12 months)
- Corticosteroid dosage(12 months)