The Use of Human Hepatocyte Transplantation as a Life Support Bridge in Terminal Liver Failure
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Survival to liver transplantation
研究概览
简要总结
The purpose of this study is to gain knowledge about the result of infusing liver cells, carefully matched to blood type, into a subject's body. The hope is that this procedure will aid functions of the liver and prevent death, enable a transplant procedure to be carried out if a donated liver becomes available, and lessen complications in postoperative recovery. There is no guarantee that any of these benefits will be re eived, but even if they are not, the hope is that knowledge gained by using this procedure will be of future benefit to others who also suffer from liver disease.
详细描述
Adult and pediatric patients eligible for liver transplantation who require intensive care unit admission for multisystem organ failure in addition to liver failure, without systemic sepsis, are eligible for liver cell transplantation regardless of race, sex or financial support.
Failure of 3 or more organ systems are the criterion used to select patients with as close to 100% mortality as possible without solid organ transplant.
Hepatocytes, isolated from excess liver tissure from reduced liver transplant procedures or from donor livers not used for transplantation, are prepared by a complex process and then are infused, guided by radiology into the splenic artery or portal vein of the patient. Patients must be on immunosuppression therapy for as long as the hepatocytes are living and beneficial to the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to VCU Health System ICU in fulminant Liver Failure in addition to multisystem organ failure
排除标准
- •Patients with Sepsis
结局指标
主要结局
Survival to liver transplantation
次要结局
- Liver Function Normalization