The Efficacy of Allogenic Bone Marrow Stem Cells Transplantation in Patients With Liver Cirrhosis Resulting From Chronic Hepatitis B
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Liver Function
研究概览
简要总结
The objective of this study is to evaluate the therapeutic efficacy of allogenic bone marrow stem cells (BMSCs) transplantation in patients with liver cirrhosis. The evaluation of the efficacy includes the level of serum alanine aminotransferase (ALT), aspartate aminotransferase(AST), total bilirubin (TB),prothrombin time (PT), albumin (ALB), prealbumin(PA), precollagenⅢ(PCⅢ), collagenⅣ(Ⅳ-C), laminin(LN), hyaluronidase(HN), liver histological improvement before and 1 week to 1 year after transplantation. Child-Pugh scores and clinical symptoms were also observed simultaneously.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Aged 16~65 years.
- •Serum HBsAg positive for over six months.
- •Ultrasonographic evidences of cirrhosis
排除标准
- •History of moderate to severe hepatic encephalopathy or variceal bleeding during the last two months before enrolment.
- •Prothrombin time is over 30s.
- •Cirrhosis caused by other reasons except HBV infection.
- •Severe problems in other vital organs(e.g.the heart,renal or lungs).
- •Liver tumor on ultrasonography, CT or MRI examination.
- •Pregnant or lactating women.
- •Imaging evidences of vascular thromboses.
研究组 & 干预措施
Group A(conserved therapy )
Thirty of the enrolled patients were assigned to Group A were received comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.
干预措施: Conserved therapy (Drug)
Group B (BMSC Transplantion)
Thirty of the enrolled patients were assigned to Group B to receive comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine, as well as bone marrow stem cells transplantation
干预措施: Allogenic bone marrow stem cells transplantation (Procedure)
结局指标
主要结局
Liver Function
时间窗: 12 months
次要结局
- Immunity(12 months)