Efficacy and Safety of Different Transplantation Routes of Human Umbilical Cord-mesenchymal Stem Cells in Patients With End-stage Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Survival rate
研究概览
简要总结
Stem cells are non-terminal cells that can self renew and replicate through symmetric or asymmetric division, with the potential to differentiate into different types of cells and tissues. Multiple studies have shown that human umbilical cord mesenchymal stem cell has good safety and effectiveness in improving acute or chronic liver injury.
Stem cell therapy for end-stage liver disease (ESLD) can be administered through various routes, among which hepatic artery and peripheral vein infusions are the most commonly used in clinical practice. The efficacy of hepatic artery infusion appears to be greater than that of peripheral vein infusion.
详细描述
Thirty-two participants with end-stage liver disease admitted to the Department of Gastroenterology of the General Hospital of Northern Theater Command are expected to be enrolled over a period of 6 months. They will be randomly assigned to peripheral vein infusion and hepatic arterial infusion of human umbilical cord mesenchymal stem cell groups. The investigators will observe alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, albumin, prothrombin time, international normalized ratio, model for end-stage liver disease score, and Child-Pugh score at weeks 4, 12, and 24 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
- •Signed 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
- •Severe coagulopathy or renal dysfunction
- •Other circumstances that are unsuitable for participation in this study
研究组 & 干预措施
Peripheral veins infusion group
Peripheral veins infusion of stem cells
干预措施: Infusion of umbilical cord-mesenchymal stem cells through peripheral veins (Other)
Hepatic arterial infusion group
Hepatic arterial infusion of stem cells
干预措施: Infusion of umbilical cord-mesenchymal stem cells through hepatic artery (Other)
结局指标
主要结局
Survival rate
时间窗: 24 weeks
Number of subjects surviving after 24 weeks
次要结局
- Changes in Model for End-Stage Liver Disease (MELD) score(4, 12, and 24 weeks)
- Changes in Child-Pugh score(4, 12, and 24 weeks)
- Incidence of hepatic decompensation events(4, 12, and 24 weeks)
研究者
Xingshun Qi
Director of Department of Gastroenterology
General Hospital of Shenyang Military Region