Bone marrow stem cell transplantation in patients with decompensated liver cirrhosis

ISRCTN	ISRCTN16139487
DOI	https://doi.org/10.1186/ISRCTN16139487
Secondary identifying numbers	N/A

Submission date: 01/04/2015
Registration date: 15/04/2015
Last edited: 17/04/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
The treatment of patients with advanced liver disease (decompensated liver cirrhosis) is very challenging. Stem cell therapy is one treatment being developed to repair damaged tissues or organs in patients using their own cells. Stem cells are found in various parts of the body, such as bone marrow, and they are important in repairing damage and maintaining healthy cells. In this study, bone marrow stem cells are taken from patients, processed and then transplanted back into patients’ bodies to help repair their damaged liver. The aim is to improve patient health and provide an in-between treatment before liver transplantation.

Who can participate?
Patients with advanced decompensated liver cirrhosis caused by chronic viral hepatitis B or C.

What does the study involve?
Bone marrow stem cells are taken from the side of the hip bone while the patient is under local anaesthetic. Patients are later injected with their own processed cells into an artery through a catheter. A follow-up visit takes place 12 months after stem cell transplantation which includes a blood test for liver function and health questionnaires.

What are the possible benefits and risks of participating?
Participants may show improved liver function following treatment with stem cells. There is a risk of mild pain at injection sites.

Where is the study run from?
N. Kipshidze Central University Hospital (Georgia)

When is the study starting and how long is it expected to run for?
February 2011 to October 2014

Who is funding the study?
N. Kipshidze Central University Hospital (Georgia)

Who is the main contact?
Prof Z Kakabadze (Georgia)
zurab.kakabadze@gmail.com

Contact information

Professor Zurab Kakabadze
Scientific

Kazbegi Ave #6
Tbilisi
0161
Georgia

ORCID ID	0000-0001-9038-5220
Phone	+995 599 970899
Email	zurab.kakabadze@gmail.com

Study information

Study design	Interventional non-randomized controlled study with two study branches.
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet.
Scientific title	Autologous bone marrow stem cell transplantation in patients with decompensated liver cirrhosis: results from first in man study
Study objectives	Our aim is to evaluate the safety and feasibility of autologous bone marrow mesenchymal stem cell (BMC) transplantation in patients with decompensated liver cirrhosis.
Ethics approval(s)	Ethics Committee of Central University Hospital, Tbilisi, Georgia, 10/12/2010, ref: 3.
Health condition(s) or problem(s) studied	Decompensated liver cirrhosis
Intervention	1. 50-100 mL of bone marrow was aspirated from the anterior iliac crest under local anesthesia 2. At least 100 million of enriched mononuclear cells was infused into the hepatic artery of the patients through a catheter for 20 minutes, using a routine technique similar to arterial chemoembolization of liver tumors
Intervention type	Procedure/Surgery
Primary outcome measure	1. Liver function (blood) test 2. Model for End-Stage Liver Disease (MELD) score 3. Child-Pugh Score for cirrhosis mortality
Secondary outcome measures	Cirrhosis mortality
Overall study start date	10/02/2011
Completion date	15/10/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	34
Key inclusion criteria	1. Chronic hepatic failure 2. Ultrasonographic evidences of cirrhosis and portal hypertension 3. Child-Pough class B and C score 4. Patients must have the ability to sign the informed consent
Key exclusion criteria	1. Patients aged less than 18 or more than 70 2. Hepatopulmonary syndrome 3. Documented hepatocellular carcinoma or history of other cancer 4. Presence of hepatic, portal or splenic vein thrombosis on doppler ultrasonography 5. History of autoimmune diseases 6. Use of hepatotoxic drugs within the last 6 month before enrolment 7. Decompensated heart failure 8. Renal failure (creatinine >2.5 mg/dL) 9. International normalized ratio (INR) >2.2 10. Patients with acute infection 11. Patients with pregnancy or lactation 12. Patients with recurrent gastrointestinal bleeding 13. Patients with spontaneous bacterial peritonitis 14. Patients unable to give informed consent
Date of first enrolment	10/02/2011
Date of final enrolment	12/04/2014

Locations

Countries of recruitment

Georgia

Study participating centre

N. Kipshidze Central University Hospital

29 Vazha-Pshavela Avenue
Tbilisi
0177
Georgia

Sponsor information

N. Kipshidze Central University Hospital (Georgia)
Hospital/treatment centre

Vazha-Pshavela Ave.#29
Tbilisi
0177
Georgia

"ROR"	https://ror.org/020jbrt22

Funders

Funder type

Hospital/treatment centre

N. Kipshidze Central University Hospital (Georgia)

No information available

Results and Publications

Intention to publish date	01/09/2015
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan
IPD sharing plan