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Autologous Bone Marrow Mesenchymal Stem Cells Transplantation Via Hepatic Artery in Patients With Liver Cirrhosis

Primary Purpose

Liver Cirrhosis

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Hepatic artery infusion
Conserved Therapy
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis focused on measuring Stem cells, Liver cirrhosis, Radiology, Interventional, Transplantation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-70 years.
  • Imaging evidences of liver cirrhosis.
  • Child-Plough score of 10 or more.

Exclusion Criteria:

  • Liver tumor on ultrasonography, CT or MRI examination.
  • Problems in organs other than the liver(e.g.the heart or lungs).
  • History of moderate to severe hepatic encephalopathy or variceal bleeding.
  • Imaging evidences of vascular thromboses.
  • Coma.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Conserved Therapy

    Interventional Therapy

    Arm Description

    Conserved Therapy

    Patients with liver cirrhosis were randomly separated into two groups. Autologous MSCs were infused to patients using interventional method via hepatic artery for One group. The catheter was inserted to proper hepatic artery. After the catheter placed at proper hepatic artery was confirmed by angiography, autologous bone marrow MSCs were infused slowly for 20-30 minutes. The control group accepted conserved therapy.

    Outcomes

    Primary Outcome Measures

    The levels of serum alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT), albumin (ALB)

    Secondary Outcome Measures

    Full Information

    First Posted
    August 31, 2009
    Last Updated
    September 14, 2009
    Sponsor
    Sun Yat-sen University
    Collaborators
    Third Affiliated Hospital, Sun Yat-Sen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00976287
    Brief Title
    Autologous Bone Marrow Mesenchymal Stem Cells Transplantation Via Hepatic Artery in Patients With Liver Cirrhosis
    Official Title
    Autologous Bone Marrow Mesenchymal Stem Cells Transplantation Via Hepatic Artery in Patients With Liver Cirrhosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2009
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2008 (undefined)
    Primary Completion Date
    December 2009 (Anticipated)
    Study Completion Date
    June 2010 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Sun Yat-sen University
    Collaborators
    Third Affiliated Hospital, Sun Yat-Sen University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to investigate the efficacy of autologous bone marrow mesenchymal stem cells (MSCs) transplantation via hepatic artery in the treatment of liver cirrhosis. Liver function was monitored by serum examination. The levels of serum alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT) and albumin (ALB) were examined at pre-transplantation, and 3 days to 2 years post-transplantation. Child-Pugh scores and clinical symptoms were also observed simultaneously.
    Detailed Description
    Patients with liver cirrhosis were randomly separated into two groups. Autologous MSCs were infused to patients using interventional method via hepatic artery for One group. The catheter was inserted to proper hepatic artery. After the catheter placed at proper hepatic artery was confirmed by angiography, autologous bone marrow MSCs were infused slowly for 20-30 minutes. The control group accepted conserved therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Liver Cirrhosis
    Keywords
    Stem cells, Liver cirrhosis, Radiology, Interventional, Transplantation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Conserved Therapy
    Arm Type
    Active Comparator
    Arm Description
    Conserved Therapy
    Arm Title
    Interventional Therapy
    Arm Type
    Experimental
    Arm Description
    Patients with liver cirrhosis were randomly separated into two groups. Autologous MSCs were infused to patients using interventional method via hepatic artery for One group. The catheter was inserted to proper hepatic artery. After the catheter placed at proper hepatic artery was confirmed by angiography, autologous bone marrow MSCs were infused slowly for 20-30 minutes. The control group accepted conserved therapy.
    Intervention Type
    Procedure
    Intervention Name(s)
    Hepatic artery infusion
    Other Intervention Name(s)
    interventional therapy
    Intervention Description
    Patients with liver cirrhosis were randomly separated into two groups. Autologous MSCs were infused to patients using interventional method via hepatic artery for One group. The catheter was inserted to proper hepatic artery. After the catheter placed at proper hepatic artery was confirmed by angiography, autologous bone marrow MSCs were infused slowly for 20-30 minutes. The control group accepted conserved therapy.
    Intervention Type
    Procedure
    Intervention Name(s)
    Conserved Therapy
    Other Intervention Name(s)
    interventional, hepatic infusion
    Intervention Description
    Conserved Therapy
    Primary Outcome Measure Information:
    Title
    The levels of serum alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT), albumin (ALB)
    Time Frame
    pre-transplantation, and 3 days to 2 years post-transplantation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18-70 years. Imaging evidences of liver cirrhosis. Child-Plough score of 10 or more. Exclusion Criteria: Liver tumor on ultrasonography, CT or MRI examination. Problems in organs other than the liver(e.g.the heart or lungs). History of moderate to severe hepatic encephalopathy or variceal bleeding. Imaging evidences of vascular thromboses. Coma.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zhu k shun, PHD
    Organizational Affiliation
    SunYat-sen University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Autologous Bone Marrow Mesenchymal Stem Cells Transplantation Via Hepatic Artery in Patients With Liver Cirrhosis

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