Trial record 2 of 318 for:    Open Studies | "Liver Cirrhosis"

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

This study is currently recruiting participants.
Verified December 2012 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Moon Young Kim, Yonsei University
ClinicalTrials.gov Identifier:
NCT01741090
First received: November 10, 2011
Last updated: December 7, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Alcoholic Liver Cirrhosis
Biological: mesenchymal stem cell injection
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • The improvement of Liver Histologic grade [ Time Frame: 6 months later ] [ Designated as safety issue: Yes ]
    according to Metavir and Laennec fibrosis scoring system


Secondary Outcome Measures:
  • The evaluation of hepatic dendritic cells activity by immunohistochemistry [ Time Frame: baseline and 6 months later ] [ Designated as safety issue: Yes ]
  • Liver fibrosis quantitative analysis using Hydroxyproline contents in liver tissue [ Time Frame: baseline and 6 months later ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Hepatic venous pressure gradient(HVPG) [ Time Frame: baseline and 6 months later ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • MELD score [ Time Frame: baseline and 6 months later ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: September 2009
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01741090

Contacts
Contact: Soon Koo Baik, M.D., PhD 82-33-741-1229 baiksk@medimail.co.kr
Contact: Moon Young Kim, M.D., PhD 82-33-741-1225 drkimmy@yonsei.ac.kr

Locations
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    baiksk@medimail.co.kr   
Contact: Moon Young Kim, M.D    82-33-741-1225    drkimmy@yonsei.ac.kr   
Principal Investigator: Soon Koo Baik, M.D         
Sub-Investigator: Moon Young Kim, M.D         
Sponsors and Collaborators
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
  More Information

Publications:

Responsible Party: Moon Young Kim, Associate Professor, Yonsei University
ClinicalTrials.gov Identifier: NCT01741090     History of Changes
Other Study ID Numbers: CR109021
Study First Received: November 10, 2011
Last Updated: December 7, 2012
Health Authority: Korea: Food and Drug Administration
Korea: Institutional Review Board

Keywords provided by Yonsei University:
Autologous Mesenchymal stem cell
alcoholic liver cirrhosis

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Liver Cirrhosis, Alcoholic
Liver Diseases
Digestive System Diseases
Pathologic Processes
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders

ClinicalTrials.gov processed this record on April 15, 2014