Condition category
Digestive System
Date applied
28/04/2009
Date assigned
18/11/2009
Last edited
24/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Phil Newsome

ORCID ID

Contact details

Centre for Liver Research
Institute of Biomedical Research
University of Birmingham
Birmingham
B15 2TT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RRK3728/HE2012

Study information

Scientific title

A multicentre, phase II, open-label, randomised controlled trial of repeated autologous infusions of granulocyte colony stimulating factor (GCSF) mobilised CD133+ bone marrow stem cells in patients with cirrhosis

Acronym

REALISTIC

Study hypothesis

Animal data suggests that haematopoietic stem cells (HSCs) and granulocyte colony stimulating factor (GCSF) play an important role in increasing hepatic regeneration and reducing hepatic fibrosis. This study aims to demonstrate the superiority of either GCSF alone or GCSF followed by repeated infusions of HSCs (CD133+ bone marrow stem cells) over standard conservative management in improving severity of liver disease over three months.

Ethics approval

Submitted to Oxfordshire Research Ethics Committe A, decision due May 2009

Study design

Multicentre phase II open-label randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Liver cirrhosis

Intervention

Trial Group 1 : Standard conservative management
Trial Group 2 : GCSF (Lenograstim) 15 µg/kg subcutaneously daily for 5 days
Trial Group 3 : GCSF (Lenograstim) 15 µg/kg subcutaneously daily for 5 days, followed by leukopharesis, isolation of CD133+ cells and reinfusion on day 6, day 30 and day 60.

Intervention type

Drug

Phase

Phase II

Drug names

Granulocyte colony stimulating factor (GCSF) (Lenograstim)

Primary outcome measures

Change in MELD score (delta MELD) from baseline (day 0) to day 90.

Secondary outcome measures

1. Changes from baseline to day 90, day 180 and day 360 in:
1.1. Enhanced Liver Fibrosis (ELF) score
1.2. Transient elastography (Fibroscan)
1.3. United Kingdom End stage Liver Disease (UKELD) score
1.4. Chronic Liver Disease Questionnaire (CLDQ) - quality of life score
1.5. Individual blood parameters
1.6. Clinical events
1.7. Transplant free survival

2. Changes from baseline to day 5 in:
2.1. Circulating CD34+ cells
2.2. Circulating CD133+ cells

Overall trial start date

01/07/2009

Overall trial end date

01/07/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females, age 18 - 70 years
2. Model for End stage Liver Disease (MELD) score 12 - 15
3. Aetiology of liver disease, one or more of:
3.1. Alcohol related liver disease
3.2. Hepatitis C
3.3. Hepatitis B
3.4. Primary biliary cirrhosis
3.5. Non-alcoholic fatty liver disease
3.6. Cryptogenic cirrhosis
3.7. Haemachromatosis
4. Cirrhosis (invasive or non-invasive diagnosis)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

81

Participant exclusion criteria

1. Inability or refusal to give informed consent
2. Alcohol consumption within recommended limits
3. Uncontrolled ascites
4. Encephalopathy in last 6 months
5. Portal hypertensive bleeding in last 6 months
6. Current or previous hepatocellular carcinoma (including dysplastic nodules)
7. Previous liver transplant
8. Listed for liver transplantation
9. Pregnancy or breastfeeding

Recruitment start date

01/07/2009

Recruitment end date

01/07/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Liver Research
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

University Hospitals Birmingham NHS Foundation Trust (UK)

Sponsor details

Research and Development Department
4th Floor Nuffield House
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom

Sponsor type

Government

Website

http://www.uhb.nhs.uk

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Biomedical Research Unit Birmingham

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Sir Jules Thorn Charitable Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25795699

Publication citations

Additional files

Editorial Notes