Repeated autologous infusions of stem cells in cirrhosis
| ISRCTN | ISRCTN91288089 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91288089 |
| Secondary identifying numbers | RRK3728/HE2012 |
- Submission date
- 28/04/2009
- Registration date
- 18/11/2009
- Last edited
- 13/11/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Phil Newsome
Scientific
Scientific
Centre for Liver Research
Institute of Biomedical Research
University of Birmingham
Birmingham
B15 2TT
United Kingdom
Study information
| Study design | Multicentre phase II open-label randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study acronym | REALISTIC |
| Study objectives | 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(s) | Submitted to Oxfordshire Research Ethics Committe A, decision due May 2009 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Granulocyte colony stimulating factor (GCSF) (Lenograstim) |
| Primary outcome measure | 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 study start date | 01/07/2009 |
| Completion date | 01/07/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 81 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/07/2009 |
| Date of final enrolment | 01/07/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Birmingham
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Sponsor information
University Hospitals Birmingham NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research and Development Department
4th Floor Nuffield House
Queen Elizabeth Hospital
Birmingham
B15 2TH
England
United Kingdom
| Website | http://www.uhb.nhs.uk |
|---|---|
"ROR" |
https://ror.org/014ja3n03 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Biomedical Research Unit Birmingham
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Sir Jules Thorn Charitable Trust
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- The Sir Jules Thorn Charitable Trust
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 20/03/2015 | Yes | No | |
| Results article | results | 01/01/2018 | Yes | No |
Editorial Notes
13/11/2017: Publication reference added.
