The Effectiveness and Safety for Mesenchymal Stem Cell for Alcoholic Liver Cirrhosis

Phase 2

• Conditions: Alcoholic Liver Cirrhosis

• Registration Number: NCT01741090
• Lead Sponsor: Yonsei University

Brief Summary

Background \& Aim: Bone marrow derived mesenchymal stem cells (BM-MSCs) have capacity to differentiate into hepatocytes and anti-fibrotic effect in the experimental model. No study was done in humans with alcoholic liver cirrhosis. The researchers investigated the anti-fibrotic effect of BM-MSCs in alcoholic cirrhosis as Phase II clinical study.

Methods: Eleven alcoholic cirrhosis patients (M:F = 10:1) with Child-Pugh's class B and maintenance of alcohol abstinence at least 2 months were enrolled. At baseline, all patients received liver biopsy, hepatic venous pressure gradient (HVPG) measurement and serologic tests. BM-MSCs were isolated from each patient's BM and amplified for one month and injected two times at 4, 8week through Rt. hepatic artery. 5x106cells/mL of BM-MSCs were injected in each session. Follow up biopsy, HVPG and relative expression of tissue transforming growth factor-1 (TGF-β1), α smooth muscle actin (α-SMA) and collagen-1 by real time RT PCR were measured after 12weeks from 2nd BM-MSC injection. The primary outcome was improvement in patients' histology Aim :

The researchers aimed to evaluate safety and effectiveness of new therapy with bone marrow derived autologous mesenchymal stem cell for hepatic failure caused by alcoholic liver cirrhosis.

Detailed Description

Autologous BM-MSCs therapy in alcoholic cirrhosis induces improvement of hepatic fibrosis in histological and quantitative measurements.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2011-11-10
• Status Verified: 2012-12
• Study First Submitted QC: 2012-12-03
• Study First Posted: 2012-12-04
• Last Update Submitted: 2012-12-07
• Last Update Posted: 2012-12-10
• Primary Completion: 2013-06
• Study Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Alcoholic liver cirrhosis(child Pugh class B or C, ≥ 7 scores),confirmed by clinically or biopsy.
2. Stop drinking over past 6months.
3. Patients agree with informed consent Patients must satisfy all inclusion criteria.

Exclusion Criteria

1. Patients who did not satisfy inclusion criteria
2. Hepatocellular carcinoma
3. Pregnancy or breast feeding
4. Infective disease(HIV, HBV, HCV..)
5. Other incurable malignancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The improvement of Liver Histologic grade	6 months later	according to Metavir and Laennec fibrosis scoring system

Secondary Outcome Measures

Name	Time	Method
The evaluation of hepatic dendritic cells activity by immunohistochemistry	baseline and 6 months later
Liver stiffness measurement with transient elastography	baseline and 6 months later	Recently, hepatic fibrosis can be estimated non-invasively using transient elastography (Fibroscan, commercial name) and it can be additive data in estimation of therapeutic response.
Liver fibrosis quantitative analysis using Hydroxyproline contents in liver tissue	baseline and 6 months later	Hydroxyproline is a essential component of collange fiber
Real-Time Polymerase Chain Reaction for relative mRNA expression of TGF-beta, collagen, procollagen, MMP2 or 9	baseline and 6 months later
Hepatic venous pressure gradient(HVPG)	baseline and 6 months later	HVPG is a gold standard to measure the portal hypertension.
Hepatic vein arrival time using microbubble contrast enhanced ultrasonography	baseline and 6 months later	Hepatic vein arrival time is related with portal hypertension and intrahepatic inflammation, neoangiogenesis and shunts formation secondary to hepatic fibrosis.
Child-Pugh score	baseline and 6 months later
MELD score	baseline and 6 months later

Trial Locations

Locations (1)

Yonsei University Wonju College of Medicine Wonju Christian Hospital; 🇰🇷 Wonju, Kangwon-do, Korea, Republic of