Condition category
Digestive System
Date applied
01/04/2015
Date assigned
15/04/2015
Last edited
17/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Professor Zurab Kakabadze

ORCID ID

http://orcid.org/0000-0001-9038-5220

Contact details

Kazbegi Ave #6
Tbilisi
0161
Georgia
+995 599 970899
zurab.kakabadze@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Autologous bone marrow stem cell transplantation in patients with decompensated liver cirrhosis: results from first in man study

Acronym

Study hypothesis

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

Ethics Committee of Central University Hospital, Tbilisi, Georgia, 10/12/2010, ref: 3.

Study design

Interventional non-randomized controlled study with two study branches.

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

10/02/2011

Overall trial end date

15/10/2014

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

34

Participant 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

Recruitment start date

10/02/2011

Recruitment end date

12/04/2014

Locations

Countries of recruitment

Georgia

Trial participating centre

N. Kipshidze Central University Hospital
29 Vazha-Pshavela Avenue
Tbilisi
0177
Georgia

Sponsor information

Organisation

N. Kipshidze Central University Hospital (Georgia)

Sponsor details

Vazha-Pshavela Ave.#29
Tbilisi
0177
Georgia

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

N. Kipshidze Central University Hospital (Georgia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

01/09/2015

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes