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

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: NCT01224327
Recruitment Status : Unknown
Verified September 2010 by Qingdao University.
Recruitment status was:  Not yet recruiting
First Posted : October 20, 2010
Last Update Posted : October 20, 2010
Sponsor:
Information provided by:
Qingdao University

Study Description
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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
Liver Cirrhosis Radiology Mesenchymal Stem Cells Umbilical Cord 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 2010
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: Drug therapy


Outcome Measures
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Primary Outcome Measures :
  1. The result of liver function and liver histological improvement. [ Time Frame: every 4 weeks ]

Secondary Outcome Measures :
  1. The disappearance or reduction of abdominal dropsy [ Time Frame: every 4 weeks ]
  2. The clinical symptom improve(including food appetite,debilitation,abdominal distension,edema of lower limbs ) [ Time Frame: every 4 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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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 ClinicalTrials.gov identifier (NCT number): NCT01224327


Contacts
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Contact: Jianxia Hu, MD 86-0532-82911676 qdyxyhjx@126.com
Contact: Hong Gao, MS 86-0532-82911676 honggaogloria@gmail.com

Locations
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China, Shandong
Stem Cell Research Center of Medical School Hospital of Qingdao University
Qingdao, Shandong, China, 266003
Contact: Jianxia Hu, MD    86-0532-82911676    qdyxyhjx@126.com   
Contact: Hong Gao, MS    86-0532-82911676    honggaogloria@gmail.com   
Principal Investigator: Zibin Tian, MD         
Sponsors and Collaborators
Qingdao University
Investigators
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Study Director: Zibin Tian, MD The Affiliated Hospital of Qingdao University
More Information
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Responsible Party: Wang, Yangang MD, Stem Cell Research Center of Medical School Hospital of Qingdao University
ClinicalTrials.gov Identifier: NCT01224327    
Other Study ID Numbers: MSCHC005
First Posted: October 20, 2010    Key Record Dates
Last Update Posted: October 20, 2010
Last Verified: September 2010
Keywords provided by Qingdao University:
Liver cirrhosis
Radiology
Mesenchymal Stem Cells
Umbilical Cord
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases