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

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ClinicalTrials.gov Identifier: NCT00976287
Recruitment Status : Unknown
Verified September 2009 by Sun Yat-sen University.
Recruitment status was:  Active, not recruiting
First Posted : September 14, 2009
Last Update Posted : September 15, 2009
Sponsor:
Collaborator:
Third Affiliated Hospital, Sun Yat-Sen University
Information provided by:
Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Procedure: Hepatic artery infusion Procedure: Conserved Therapy Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Autologous Bone Marrow Mesenchymal Stem Cells Transplantation Via Hepatic Artery in Patients With Liver Cirrhosis
Study Start Date : January 2008
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Arm Intervention/treatment
Active Comparator: Conserved Therapy
Conserved Therapy
Procedure: Conserved Therapy
Conserved Therapy
Other Names:
  • interventional
  • hepatic infusion

Experimental: Interventional 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.
Procedure: Hepatic artery infusion
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.
Other Name: interventional therapy




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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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:

  • 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.

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): NCT00976287


Sponsors and Collaborators
Sun Yat-sen University
Third Affiliated Hospital, Sun Yat-Sen University
Investigators
Study Director: Zhu k shun, PHD SunYat-sen University

Additional Information:
Responsible Party: Sun Yat-sen university
ClinicalTrials.gov Identifier: NCT00976287     History of Changes
Other Study ID Numbers: zssy
First Posted: September 14, 2009    Key Record Dates
Last Update Posted: September 15, 2009
Last Verified: September 2009

Keywords provided by Sun Yat-sen University:
Stem cells
Liver cirrhosis
Radiology
Interventional
Transplantation

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