The Use of Human Hepatocyte Transplantation as a Life Support Bridge in Terminal Liver Failure.
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- The functional capability of transplanted hepatocytes to assume function in the native liver.
研究概览
简要总结
The investigators research will examine the safety and efficacy of hepatocyte transplantation in the patient with acute liver failure without history of chronic disease. The investigators will study the effectiveness in providing a bridge of support for patient survival until whole organ transplantation is possible. This support may also be a bridge to recovery; by allowing the native liver to recover so that orthotopic liver transplant is not necessary.
The investigators will also study the safety and efficacy of hepatocyte transplantation in the patient with chronic liver disease. Underlying etiologies of chronic disease may arise from cirrhosis, fibrosis or inherited metabolic disorders. The investigators will examine cell transplantation in end-stage patients not eligible for whole organ transplant. These patients may benefit with an amelioration of symptoms that will allow other therapeutic treatments.
The investigators study will also examine the ability of transplanted hepatocytes to treat inherited metabolic diseases (ex., Crigler-Najjar Disease, Familial Hypercholesterolemia, Urea Cycle Disorders). Cell transplant may also act as a 'bridge' to whole organ transplant or improve function, permitting easier disease control through traditional therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria are specific to the classification of liver disease, i.e., fulminant or non-fulminant or metabolic disease
排除标准
- •Any systemic infection
- •Unstable coronary artery disease
- •HIV infection
- •Preformed antibodies to class antigens that are present on all available donor samples (Only cells from an ABO-compatible donor with no HLA Class I antigen to which the recipient has preformed antibodies will be selected for transplant.)
- •Hepatopulmonary disease (Room air Pa02 ≤ 60 mmHg)
- •Testing positive for Hepatitis B Surface Antigen (HBsAg), Hepatitis Be antigen (HBeAg) or Hepatitis B Virus by DNA and unable to receive or pay for Hepatitis B treatment.
- •Any current or anticipated contraindication for the use of tacrolimus and cyclosporine, methylprednisolone or prednisone.
- •Female patients who are breast feeding
- •Any medical condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this trial.
结局指标
主要结局
The functional capability of transplanted hepatocytes to assume function in the native liver.
时间窗: Outcome measurements will be assessed weekly through week two post transplant, then monthly through month 12, then every six months.
次要结局
未报告次要终点