Chronic liver insufficiency MedDRA version: 9.1 Level: LLT Classification code 10024667 Term: Liver cirrhosis MedDRA version: 9.1 Level: LLT Classification code 10024670 Term: Liver disorder
Conditions
Interventions
Product Name: Autologous stem cells
Pharmaceutical Form: Intravenous infusion
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the maximum tolerated dose of expanded autologous cells derived from a subset of CD34+ stem cells when infused into either the hepatic artery or the portal vein. The trial will also seek to determine clinical improvement or deterioration by measurement of clinical parameters such as liver function tests.;Secondary Objective: To assess improvement in liver function as measured by serological and biochemical analysis and determine whether there are any symptomatic improvements as reported by the patients.;Primary end point(s): To assess the safety of ascending doses of autologous adult stem cells when introduced into either the hepatic artery or the portal vein and to determine the maximum tolerated dose of stem cells. The route of delivery is determined by radiological opinion. | — |
Countries
United Kingdom
Outcome results
None listed