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Umbilical Cord Mesenchymal Stem Cells Infusion Via Hepatic Artery in Cirrhosis Patients

Sponsor
Qingdao University (Other)
Overall Status
Unknown status
CT.gov ID
NCT01224327
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
26
Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the efficacy of umbilical cord mesenchymal stem cells (MSCs) infusion via hepatic artery in the treatment of liver cirrhosis.

Condition or Disease Intervention/Treatment Phase
  • Biological: umbilical cord Mesenchymal Stem Cells
  • Drug: Conserved therapy
 Phase 1/Phase 2

Detailed Description

To investigate the efficacy of umbilical cord mesenchymal stem cells (MSCs) infusion via hepatic artery in the treatment of liver cirrhosis. Patients with liver cirrhosis were randomly separated into two groups. Umbilical cord MSCs were infused to patients using interventional method via hepatic artery for One group. After the catheter placed at proper hepatic artery was confirmed by angiography, umbilical cord MSCs were infused slowly for 15-20minutes. The control group accepted conserved therapy.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion Via Hepatic Artery in Cirrhosis Patients.
Study Start Date :
Oct 1, 2010
Anticipated Primary Completion Date :
Oct 1, 2012
Anticipated Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: umbilical cord mesenchymal stem cells

Umbilical cord mesenchymal stem cells were infused to patients using interventional method via hepatic artery. After the catheter placed at proper hepatic artery was confirmed by angiography,umbilical cord MSCs were infused slowly for 15-20minutes.

Biological: umbilical cord Mesenchymal Stem Cells
Umbilical cord mesenchymal stem cells were infused to patients using interventional method via hepatic artery. After the catheter placed at proper hepatic artery was confirmed by angiography,umbilical cord MSCs were infused slowly for 15-20minutes.
Other Names:
  • Mesenchymal Stem Cells

    		•
    Active Comparator: Conserved therapy

    Patients received comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.

    Drug: Conserved therapy
    Oral or intravenous administration
    Other Names:
  • Drug therapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The result of liver function and liver histological improvement. [every 4 weeks]

    Secondary Outcome Measures

    1. The disappearance or reduction of abdominal dropsy [every 4 weeks]

    2. The clinical symptom improve(including food appetite,debilitation,abdominal distension,edema of lower limbs ) [every 4 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Aged 18~70 years.

    • Liver cirrhosis

    • written consent

    Exclusion Criteria:

    • The end-stage of liver cirrhosis.

    • Severe problems in other vital organs(e.g.the heart,renal or lungs).

    • Hepatocellular carcinoma or other malignancies

    • Pregnancy

    • sepsis

    • Presence of significant extrahepatic biliary disease (e.g. CBD stone, PSC, etc.)

    • Cardiac, renal or respiratory failure

    • Active thrombosis of the portal or hepatic veins

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stem Cell Research Center of Medical School Hospital of Qingdao University Qingdao Shandong China 266003

    Sponsors and Collaborators

    • Qingdao University

    Investigators

    • Study Director: Zibin Tian, MD, The Affiliated Hospital of Qingdao University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01224327
    Other Study ID Numbers:
    • MSCHC005
    First Posted:
    Oct 20, 2010
    Last Update Posted:
    Oct 20, 2010
    Last Verified:
    Sep 1, 2010
    Keywords provided by , ,
    Liver cirrhosis
    Radiology
    Mesenchymal Stem Cells
    Umbilical Cord
    Additional relevant MeSH terms:
    Liver Cirrhosis
    Fibrosis

    Study Results

    No Results Posted as of Oct 20, 2010