NCT01322906Unknown2 期
Allogeneic Bone Marrow Mesenchymal Stem Cells Transplantation in Patients With Liver Failure Caused by HBV
Sun Yat-sen University0 个研究点目标入组 120 人开始时间: 2011年3月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 主要终点
- Liver Function
研究概览
简要总结
Allogeneic Bone Marrow Mesenchymal Stem Cells Transplantation in Patients with Liver Failure Caused by hepatitis B virus (HBV)
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
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Liver failure caused by HBV
- •Model for End-Stage Liver Disease (MELD) < 30
排除标准
- •Liver Failure caused by other reasons, such as autoimmune diseases, alcohol, drug and so on.
- •History of moderate to severe hepatic encephalopathy or variceal bleeding during the last two months before enrollment.
- •Severe problems in other vital organs (e.g.the heart,renal or lungs).
- •Tumor on ultrasonography, CT or MRI examination.
- •Pregnant or lactating women.
- •HIV infection.
结局指标
主要结局
Liver Function
时间窗: 12months
The levels of serum alanine aminotransferase (ALT), aspartate aminotransferase(AST),total bilirubin (TB),prothrombin time (PT), prothrombin activity(PTA),INR,albumin (ALB),globulin(GLB), prealbumin(PA),creatinine(Cr), Urea nitrogen(BUN),number of leucocyte,erythrocyte and platelet, cytokines,liver histological
Immune state
时间窗: 12months
cytokine
次要结局
未报告次要终点
研究者
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