EUCTR2005-001222-83-GB进行中（未招募）1 期
A phase I/II safety and tolerability dose escalation study following the autologous infusion of expanded adult haemopoietic stem cells to patients with liver insufficiency - Dose escalation autologous stem cell study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 5
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
入选标准
- •Male or female patients aged from 18 to 75 years of age with documented evidence of chronic liver insufficiency due to chronic alcohol abuse, viral hepatitis, blood clotting disorders, and/or autoimmune disease.
- •Patients with severe renal, cardiac or other diseases providing these are not immediately life threatening
- •Abnormal serum albumin and/or bilirubin and/or prothrombin time
- •Patients who are unlikely to receive a liver transplant
- •WHO performance score of less than 2 with a life expectancy of at least 3 months
- •Able to give written consent
- •Women of childbearing potential may be included, but must use a reliable and appropriate contraceptive method
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years)
- •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
- •Patients below the age of 18 or above the age of 75 years
- •Pregnant or lactating women
- •Patients with recent recurrent GI bleeding or spontaneous bacterial peritonitis
- •Patients with HIV or other life threatening infection
- •Patients with a history of drug abuse
- •Patients unable to give written consent
- •Patients with a history of hypersensitivity to G-CSF
- •Patients who have been included in any other clinical trial within the previous month
研究者
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