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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.
 
ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Moon Young Kim, Yonsei University

Tracking Information
First Submitted Date  ICMJE November 10, 2011
First Posted Date  ICMJE December 4, 2012
Last Update Posted Date December 10, 2012
Study Start Date  ICMJE September 2009
Estimated Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2012)
The improvement of Liver Histologic grade [ Time Frame: 6 months later ]
according to Metavir and Laennec fibrosis scoring system
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2012)
  • The evaluation of hepatic dendritic cells activity by immunohistochemistry [ Time Frame: 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
  • Real-Time Polymerase Chain Reaction for relative mRNA expression of TGF-beta, collagen, procollagen, MMP2 or 9 [ Time Frame: 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.
  • 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.
  • 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.
  • Child-Pugh score [ Time Frame: baseline and 6 months later ]
  • MELD score [ Time Frame: baseline and 6 months later ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2012)
  • The evaluation of hepatic dendritic cells activity by immunohistochemistry [ Time Frame: baseline and 6 months later ]
  • Liver fibrosis quantitative analysis(Hydroxyproline) [ Time Frame: baseline and 6 months later ]
  • Real-Time Polymerase Chain Reaction (TGF-beta, collagen, procollagen, MMP2 or 9) [ Time Frame: baseline and 6 months later ]
  • Hepatic vein pressure gradient [ Time Frame: baseline and 6 months later ]
  • Hepatic vein arrival time [ Time Frame: baseline and 6 months later ]
  • Fibroscan [ Time Frame: baseline and 6 months later ]
  • Child-Pugh score [ Time Frame: baseline and 6 months later ]
  • MELD score [ Time Frame: baseline and 6 months later ]
  • The change of ascites [ Time Frame: baseline and 6months later ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effectiveness and Safety for Mesenchymal Stem Cell for Alcoholic Liver Cirrhosis
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alcoholic Liver Cirrhosis
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Biological: mesenchymal stem cell injection
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 3, 2012)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2013
Estimated Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01741090
Other Study ID Numbers  ICMJE CR109021
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Moon Young Kim, Yonsei University
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Soon Koo Baik, M.D Yonsei University Wonju College of Medicine Department of Internal Medicine Devision of Gastroenterology and Hepatology
PRS Account Yonsei University
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP