MSC for ABO Incompatible Liver Transplantation
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Efficacy: one year graft survival rate
研究概览
简要总结
The purpose of this study is to determine whether MSCs are safe and effective in reducing the primary nonfunction (PNF), acute rejection and Ischemic-type Biliary Lesions (ITBLs) morbidity in ABO-incompatible Liver Transplantation.
详细描述
ABO incompatible liver transplantations is considered to be a rescue option in emergency transplantation.The A、B antibodies to grafts bind to the graft endothelium and activate complement, which attracts and activates neutrophils and platelets and increases the permeability of the endothelium. The neutrophils exude, the platelets aggregate, and the small vessels of the graft get thrombosed, resulting in ischemic damage,leading nonfunction grafts.In addition, if the A、 B antibodies remain high level, it can lead to acute humoral immune rejection. A lot of research confirmed that the ABO incompatible is a risk factor of postoperative short- and long-term survival. And mesenchymal stromal cells (MSCs) are characterized by the properties of immunosuppressive and regenerative properties, which make MSCs great attractive in treating immunological diseases (including transplant rejection) and organ/tissue ischemic injury. So we conduct this clinical study,to confirm the effect of MSCs in ABO incompatible liver transplantation by comparing the incidence of primary nonfunction, acute rejection, biliary complications and survival rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First liver transplantation with a ABO-incompatible graft(B→A，AB→A，A→B，AB→B，A→O，B→O，AB→O).
- •Ages of 18 or older.
- •Patients receive liver transplantation due to benign end stage liver disease.
- •Patients or legal agent must be able to give informed consent.
排除标准
- •Second or combined organ transplant recipient.
- •Combined transplantations such as simultaneous liver/kidney transplants
- •Malignant disease.
- •Uncontrol bacterial, fungal, viral or parasitic infection.
- •Withdraw or unable to finish the follow-up.
- •Unwilling to sign informed consent.
结局指标
主要结局
Efficacy: one year graft survival rate
时间窗: one year
次要结局
- the rate of ischemic-type biliary lesions(one year)
- the rate of acute rejection(one year)
- safety: rate of (serious) adverse events in the study population(one year)
研究者
Yang Yang
Department of Liver Transplantation
Third Affiliated Hospital, Sun Yat-Sen University