Bone marrow stem cell transplantation in patients with decompensated liver cirrhosis

Completed

• Conditions: Decompensated liver cirrhosis; Digestive System; Chronic Liver Disease/Cirrhosis

• Registration Number: ISRCTN16139487
• Lead Sponsor: . Kipshidze Central University Hospital (Georgia)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-15
• Last Update Posted: 6 July 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 34

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Liver function (blood) test<br>2. Model for End-Stage Liver Disease (MELD) score<br>3. Child-Pugh Score for cirrhosis mortality

Secondary Outcome Measures

Name	Time	Method
Cirrhosis mortality