Phase Ι/Π Study of Human Umbilical Cord Mesenchymal Stem Cells Transplantation for Patients With Decompensated Liver Cirrhosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
Although liver transplantation provide a option to cure patients suffering with decompensated liver cirrhosis this condition, lack of donors, postoperative complications, especially rejection, and high cost limit its application. Bone marrow derived mesenchymal stem cells (BM-MSCs) have been shown to replace hepatocytes in injured liver, effectively rescued experimental liver failure and contributed to liver regeneration, which suggest the novel and promising therapeutic strategy In this study, the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSCs) transplantation for patients with decompensated liver cirrhosis will be evaluated.
详细描述
To investigate the safety and efficacy of human umbilical cord mesenchymal stem cells transplantation in patients of decompensated liver cirrhosis.
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
- •Written informed consent.
- •Aged 18-70 years.
- •Decompensated liver cirrhosis, Child-Pugh B/C (7-12 points); or Meld score≦
- •Expecting lifetime is over 2 months.
- •Hepatitis B decompensated liver cirrhosis patients need antiviral therapy.
排除标准
- •Severe drug allergic history or anaphylaxis.
- •Severe problems in other vital organs(e.g. the heart, renal or lungs)
- •Severe problems in psychiatric disease,such as Schizophrenia,et al
- •Severe bacteria infection.
- •Malignancies.
- •Alcoholism or drug abuse.
- •Plan to have liver transplantation in 3 months.
- •Pregnancy
- •Candidates who are participating in other study.
结局指标
主要结局
Overall Survival (OS)
时间窗: 1 year after treatment
次要结局
- Liver function improvement(1 year after treatment)
- The size of liver and the width of portal venous(1 year after treatment)
- Incidence of hepatocellular carcinoma within 1 year(1 year after treatment)
- Child-Pugh score, MELD score,SF36-quality of life (SF36-QOL)(1 year after treatment)
- The clinical symptom improvement(including appetite, debilitation, abdominal distension, edema of lower limbs, et al )(1 year after treatment)