Efficacy and Safety of Different Dosage of Umbilical Cord-mesenchymal Stem Cells Through Peripheral Vein in Patients With End-stage Liver Diseases
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Survival rate
研究概览
简要总结
There is a rise in the prevalence of end-stage liver disease during the last decade. End-stage liver disease has become one of the leading causes of death in Western countries. Liver transplantation is the only curative treatment for patients with end-stage liver disease. However, the shortage of donor, high cost, and postoperative complications limit its wide application in clinical practice. At present, stem cell-based therapy has been developed as an alternative treatment for end-stage liver disease. Stem cells can be differentiated into a variety of cell types, and stem cell transplantation, mainly umbilical cord-mesenchymal stem cells, has attracted more and more attention in the treatment of end-stage liver disease. The investigators therefore conduct a randomised controlled trial to investigate the efficacy and safety of human umbilical cord tissue mesenchymal stem cells for the treatment of end-stage liver disease.
详细描述
Twenty-two subjects with end-stage liver disease attending the Department of Gastroenterology of the General Hospital of the Northern Theatre of Operations are expected to be enrolled over a period of 1 year. The participants will be randomly divided into a low-dose stem cell group (1×10^6cells/kg per infusion) and a medium-high-dose stem cell group (3×10^6cells/kg per infusion), which are infused by peripheral vein. The investigators will observe ALT, AST, ALP, TBIL, ALB, PT, INR, MELD score, and Child-Pugh score in patients at weeks 1, 4, 8, 12, 24, and 48 post-infusion.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years old
- •End-stage liver disease
- •Sign informed consent
排除标准
- •Tumours of the liver or other organs
- •Liver transplantation recipients
- •Acute myocardial infarction, acute heart failure, type I and type II respiratory failure, pulmonary embolism, acute cerebral infarction, acute cerebral haemorrhage and other serious cardiopulmonary diseases
- •Other diseases that may seriously affect the survival
- •Human immunodeficiency syndrome
- •Interferon or glucocorticoid therapy within 1 year
- •Treated for mental illness
- •Participation in other clinical trials within 30 days
- •Pregnant or breastfeeding subjects
- •Allergic asthma, allergic urticaria, eczema, or a history of multiple drug and food allergies
- •Other circumstances that are unsuitable for participation in this study
研究组 & 干预措施
low-dose stem cell group (1×10^6cells/kg per infusion)
Peripheral intravenous infusion of low-dose stem cells
干预措施: umbilical cord-mesenchymal stem cells (Biological)
medium-high-dose stem cell group (3×10^6cells/kg per infusion)
Peripheral intravenous infusion of medium-high-dose stem cells
干预措施: umbilical cord-mesenchymal stem cells (Biological)
结局指标
主要结局
Survival rate
时间窗: 1 year
Number of subjects surviving after one year
次要结局
- Changes in liver function(1, 4, 8, 12, 24, and 48 weeks)
- Incidence of hepatic decompensation events(1 year)
研究者
Xingshun Qi
Director of Department of Gastroenterology
General Hospital of Shenyang Military Region