EUCTR2005-000837-39-GB进行中（未招募）不适用
Open, randomized, prospective, controlled, multicentre study to evaluate the efficacy and safety of multiple intraportal applications of liver cell suspension in patients with acute liver failure not eligible for orthotopic liver transplantation
Cytonet GmbH & Co. KG0 个研究点目标入组 90 人开始时间: 2007年10月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age 18 years and above
- •Patient suffering from ALF defined as
- •- Hepatic encephalopathy grade >= 1
- •- INR > 2,0
- •- GOT, GPT and GLDH increased by at least 3 times UNL in absence of signs of
- •chronic liver disease ( = no fibrosis or cirrhosis)
- •Patient expected to be not eligible for orthotopic liver transplantation
- •Written informed consent before enrolment
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Acute liver insufficiency in presence of symptomatic chronicliver disease (fibrosis or
- •cirrhosis of the liver)
- •- Acute liver failure in case of transplant primary non-function
- •- Acute liver failure due to Budd-Chiari-Syndrome or venoocclusive disease
- •- Thrombosis of portal vein or persisting impairment of anterograde portal blood flow
- •- Allergic disposition for antibiotics used during manufacturing of liver cell transplants
- •- Encephalopathy other than hepatic
- •- Massive ascites (> 3 l)
- •- Malignancies except basaliomes
- •- Clinically manifest acquired immunodeficiency syndrome (AIDS)
- •- Contraindication to immunosuppressive therapy (e.g. severe acute bacterial, viral
- •or fungal infection, intolerability to immune suppression)
- •- Treatment with extracorporeal liver assist devices (e.g. MARS,
- •- Prometheus, HepatAssist)
- •- Pregnancy or lactation
- •- Participation in another clinical trial within the last 30 days
研究者
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