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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Qingdao University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Qingdao University
ClinicalTrials.gov Identifier:
NCT01224327
First received: October 18, 2010
Last updated: October 19, 2010
Last verified: September 2010
History of Changes
  Purpose

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 Intervention Phase
Liver Cirrhosis
Radiology
Mesenchymal Stem Cells
Umbilical Cord
 Biological: umbilical cord Mesenchymal Stem Cells
Drug: Conserved therapy
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion Via Hepatic Artery in Cirrhosis Patients.

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis X-Rays
U.S. FDA Resources

Further study details as provided by Qingdao University:

Primary Outcome Measures:
  • The result of liver function and liver histological improvement. [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The disappearance or reduction of abdominal dropsy [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]
  • The clinical symptom improve(including food appetite,debilitation,abdominal distension,edema of lower limbs ) [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01224327

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

Locations
China, Shandong
Stem Cell Research Center of Medical School Hospital of Qingdao University Not yet recruiting
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
Study Director: Zibin Tian, MD The Affiliated Hospital of Medical College of Qingdao University
  More Information

No publications provided

Responsible Party: Wang, Yangang MD, Stem Cell Research Center of Medical School Hospital of Qingdao University
ClinicalTrials.gov Identifier: NCT01224327     History of Changes
Other Study ID Numbers: MSCHC005
Study First Received: October 18, 2010
Last Updated: October 19, 2010
Health Authority: China: Ministry of Health

Keywords provided by Qingdao University:
Liver cirrhosis
Radiology
Mesenchymal Stem Cells
Umbilical Cord

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013