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

Phase 1

• Conditions: 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

• Registration Number: EUCTR2005-001222-83-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-03
• Study Completion: 2009-04-30
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 5

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.