A MULTICENTRE, PHASE II, OPEN LABEL, RANDOMISED CONTROLLED TRIAL OF REPEATED AUTOLOGOUS INFUSIONS OF G-CSF MOBILISED CD133+ BONE MARROW STEM CELLS IN PATIENTS WITH CIRRHOSIS - REpeated AutoLogous Infusions of STem cells In Cirrhosis (REALISTIC)

Phase 1

• Conditions: iver Cirrhosis; MedDRA version: 14.1 Level: PT Classification code 10001806 Term: Alpha-1 anti-trypsin deficiency System Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 14.1 Level: LLT Classification code 10009211 Term: Cirrhosis liver System Organ Class: 10019805 - Hepatobiliary disorders; MedDRA version: 14.1 Level: LLT Classification code 10024667 Term: Liver cirrhosis System Organ Class: 10019805 - Hepatobiliary disorders; MedDRA version: 14.1 Level: LLT Classification code 10064844 Term: Compensated cirrhosis System Organ Class: 10019805 - Hepatobiliary disorders; MedDRA version: 14.1 Level: PT Classification code 10019641 Term: Hepatic cirrhosis System Organ Class: 10019805 - Hepatobiliary disorders

• Registration Number: EUCTR2009-010335-41-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-06-05
• Study Completion: 2016-05-18
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 81

Inclusion Criteria

Age 18-70 inclusive
Model of End stage Liver Disease (MELD) Score between 11.50 = MELD < 15.50
Aetiology, one or more of: Alcoholic Liver Disease (ALD)
Hepatitis C (HCV)
Hepatitis B (HBV)
Primary Biliary Cirrhosis (PBC)
Non Alcholic Fatty Liver Disease (NAFLD)
Genetic Haemachromatosis
Cryptogenic Cirrhosis
Alpha-1 Antitrypsin deficiency
Cirrhosis, invasive or non-invasive diagnosis

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Decompensated Liver Disease - uncontrolled ascites, recent (last 6 months) encephalopathy, recent (last 6 months) portal hypertensive bleeding
Listed for transplantation
Previous Liver Transplant
Hepatocellular Carcinoma / Dysplastic Hepatic Nodules

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary aim of the trial is to examine whether administering either G-CSF alone or G-CSF followed by repeated infusions of stem cells is better than standard supportive care in improving severity of liver disease over 3 months. ;<br> Primary end point(s): The primary outcome measure will be change in MELD (Model for End stage Liver Disease) score (delta MELD) calculated using MELD at randomisation (Day 0) and Day 90 MELD.<br> ;<br> Secondary Objective: The secondary aims are to examine whether either G-CSF alone or G-CSF followed by repeated stem cell infusions is better than standard supportive care in:<br> a)reducing the amount of scarring in the liver<br> b)improving quality of life<br> c)reducing the number of complications related to liver disease<br> d)improving survival (without needing a transplant)<br>