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

December 7, 2012 updated by: Moon Young Kim, Yonsei University

The Evaluation of Effectiveness and Safety for New Therapy With Bone Marrow Derived Autologous Mesenchymal Stem Cell for Hepatic Failure Caused by Alcoholic Liver Cirrhosis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
    • Kangwon-do
      • Wonju, Kangwon-do, Korea, Republic of, 220-701
        • Recruiting
        • Yonsei University Wonju College of Medicine Wonju Christian Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Soon Koo Baik, M.D
        • Sub-Investigator:
          • Moon Young Kim, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MSC injection
This study is designed as single interventional arm without comparative arm. MSC injection means hepatic artery catheterizations and mesenchymal stem cell injection through catheter.
Biological: mesenchymal stem cell injection
Hepatic artery catheterization and mesenchymal stem cell injection will be used in alcoholic liver cirrhosis. And before and 1 month after injection, change of liver cirrhosis and portal hypertension will be evaluated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The improvement of Liver Histologic grade
Time Frame: 6 months later
according to Metavir and Laennec fibrosis scoring system
6 months later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The evaluation of hepatic dendritic cells activity by immunohistochemistry
Time Frame: baseline and 6 months later
baseline and 6 months later
Liver fibrosis quantitative analysis using Hydroxyproline contents in liver tissue
Time Frame: baseline and 6 months later
Hydroxyproline is a essential component of collange fiber
baseline and 6 months later
Real-Time Polymerase Chain Reaction for relative mRNA expression of TGF-beta, collagen, procollagen, MMP2 or 9
Time Frame: baseline and 6 months later
baseline and 6 months later
Hepatic venous pressure gradient(HVPG)
Time Frame: baseline and 6 months later
HVPG is a gold standard to measure the portal hypertension.
baseline and 6 months later
Hepatic vein arrival time using microbubble contrast enhanced ultrasonography
Time Frame: 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.
baseline and 6 months later
Liver stiffness measurement with transient elastography
Time Frame: 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.
baseline and 6 months later
Child-Pugh score
Time Frame: baseline and 6 months later
baseline and 6 months later
MELD score
Time Frame: baseline and 6 months later
baseline and 6 months later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Soon Koo Baik, M.D, Yonsei University Wonju College of Medicine Department of Internal Medicine Devision of Gastroenterology and Hepatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Anticipated)

June 1, 2013

Study Completion (Anticipated)

August 1, 2013

Study Registration Dates

First Submitted

November 10, 2011

First Submitted That Met QC Criteria

December 3, 2012

First Posted (Estimate)

December 4, 2012

Study Record Updates

Last Update Posted (Estimate)

December 10, 2012

Last Update Submitted That Met QC Criteria

December 7, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR109021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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