Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells Transplantation Combined With Plasma Exchange for Patients With Acute-on-Chronic Liver Failure Caused by Hepatitis B Virus (HBV)
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Survival rate and time
研究概览
简要总结
Liver failure (LF) is a dramatic clinical syndrome with massive necrosis of liver cells. Although liver transplantation provides an option to cure patients suffering with LF, lack of donors, postoperative complications, especially rejection, and high cost limit its application. Previous study showed that bone marrow derived mesenchymal stem cells (BM-MSCs) the novel and promising therapeutic strategy, BM-MSCs can replace hepatocytes in injured liver, and effectively rescue experimental liver failure and contribute to liver regeneration. Plasma exchange (PE) can improve internal environment by removing endotoxin, it helps the liver regeneration and functional recovery and make UC-MSC differentiation into hepatocyte like cells, and exert immunomodulatory function. In this study, safety and efficacy of human umbilical cord mesenchymal stem cells (UC-MSCs) transplantation combined with plasma exchange (PE) for patients with liver failure caused by hepatitis B Virus will be evaluated.
详细描述
To investigate safety and efficacy of human umbilical cord mesenchymal stem cells (UC-MSCs) transplantation combined with plasma exchange (PE) for patients with liver failure caused by hepatitis B virus.
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
- •Written informed consent
- •Acute-on-Chronic liver failure caused by hepatitis B virus
- •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 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)
- •Severe bacteria infection
- •Tumor on ultrasonography, CT or MRI examination
- •Pregnant or lactating women
结局指标
主要结局
Survival rate and time
时间窗: 48 weeks
次要结局
- Improve biochemical indexes [alanine aminotransferase (ALT), albumin (ALB), total bilirubin (TBIL), prothrombin time (PT), INR and so on](24 weeks after treatment)
- The clinical symptom improvement [including appetite, debilitation, abdominal distension, edema of lower limbs, et al](24 weeks after treatment)
- Liver function evaluation using Child-Pugh score and MELD score(24 weeks after treatment)
- Immune function improvement [including Th1/Th2](24 weeks after treatment)
- The occurrence of complications [including body temperature, tetter and allergy](Between 0 to 8 hours after UC-MSCs transfusion)
- Incidence of hepatocellular carcinoma(48 weeks after treatment)
研究者
Zhiliang Gao
Professor
Third Affiliated Hospital, Sun Yat-Sen University