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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01741090
Recruitment Status : Unknown
Verified December 2012 by Moon Young Kim, Yonsei University.
Recruitment status was:  Recruiting
First Posted : December 4, 2012
Last Update Posted : December 10, 2012
Information provided by (Responsible Party):
Moon Young Kim, 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.

Condition or disease Intervention/treatment Phase
Alcoholic Liver Cirrhosis Biological: mesenchymal stem cell injection Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2009
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

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.

Primary Outcome Measures :
  1. The improvement of Liver Histologic grade [ Time Frame: 6 months later ]
    according to Metavir and Laennec fibrosis scoring system

Secondary Outcome Measures :
  1. The evaluation of hepatic dendritic cells activity by immunohistochemistry [ Time Frame: baseline and 6 months later ]
  2. 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

  3. Real-Time Polymerase Chain Reaction for relative mRNA expression of TGF-beta, collagen, procollagen, MMP2 or 9 [ Time Frame: baseline and 6 months later ]
  4. Hepatic venous pressure gradient(HVPG) [ Time Frame: baseline and 6 months later ]
    HVPG is a gold standard to measure the portal hypertension.

  5. 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.

  6. 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.

  7. Child-Pugh score [ Time Frame: baseline and 6 months later ]
  8. MELD score [ Time Frame: baseline and 6 months later ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01741090

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Contact: Soon Koo Baik, M.D., PhD 82-33-741-1229
Contact: Moon Young Kim, M.D., PhD 82-33-741-1225

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Korea, Republic of
Yonsei University Wonju College of Medicine Wonju Christian Hospital Recruiting
Wonju, Kangwon-do, Korea, Republic of, 220-701
Contact: Soon Koo Baik, M.D    82-33-741-1229   
Contact: Moon Young Kim, M.D    82-33-741-1225   
Principal Investigator: Soon Koo Baik, M.D         
Sub-Investigator: Moon Young Kim, M.D         
Sponsors and Collaborators
Yonsei University
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Principal Investigator: Soon Koo Baik, M.D Yonsei University Wonju College of Medicine Department of Internal Medicine Devision of Gastroenterology and Hepatology

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Moon Young Kim, Associate Professor, Yonsei University Identifier: NCT01741090    
Other Study ID Numbers: CR109021
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: December 10, 2012
Last Verified: December 2012
Keywords provided by Moon Young Kim, Yonsei University:
Autologous Mesenchymal stem cell
alcoholic liver cirrhosis
Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Cirrhosis, Alcoholic
Pathologic Processes
Liver Diseases
Digestive System Diseases
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders