Mesenchymal Stem Cells Treat Liver Cirrhosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2010 by Chinese Academy of Sciences
Sponsor:
Collaborator:
Soochow University
Information provided by:
Chinese Academy of Sciences
ClinicalTrials.gov Identifier:
NCT01233102
First received: October 25, 2010
Last updated: November 2, 2010
Last verified: October 2010

October 25, 2010
November 2, 2010
October 2009
December 2010   (final data collection date for primary outcome measure)
  • The level of serum alanine aminotransferase (ALT) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The level of serum total bilirubin (TB) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The level of serum prothrombin time (PT) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The level of serum prealbumin(PA) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The level of serum albumin (ALB) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01233102 on ClinicalTrials.gov Archive Site
  • liver biopsy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The level of serum alanine aminotransferase (ALT) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The level of serum total bilirubin (TB) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The level of serum prothrombin time (PT) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The level of serum albumin (ALB) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Mesenchymal Stem Cells Treat Liver Cirrhosis
Umbilical Cord Mesenchymal Stem Cell Transfusion in Patients With Severe Liver Cirrhosis

The purpose of this study is to investigate the efficacy of umbilical cord mesenchymal stem cells (MSCs) transfusion in the treatment of liver cirrhosis. Liver function will be monitored by serum analysis. The levels of serum alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT), prealbumin(PA) and albumin (ALB) will be examined at pre-transfusion, and 3 days to 2 years post-transfusion. Child-Pugh scores, Model for End-Stage Liver Disease scores and clinical symptoms will be assessed simultaneously.

Patients with liver cirrhosis will be randomly divided into three groups. Umbilical cord MSCs will be infused to patients using interventional method via hepatic artery for one group. The catheter will be inserted to proper hepatic artery. After the catheter placement confirmed by angiography, umbilical cord MSCs will be infused slowly in 20-30 minutes. Umbilical cord MSCs will be infused intravenously slowly in 30-60 minutes in the intravenous infusion group. The control group will receive conserved therapy. The levels of serum alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT), prealbumin(PA)and albumin (ALB) will be examined at re-transplantation, and 3 days to 2 years post-transplantation. The efficacy of umbilical cord MSCs transfusion will be investigated. The efficacy of different interventional therapies will also be compared.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Liver Cirrhosis
  • Drug: Conserved Therapy
    Conserved Therapy
  • Procedure: Hepatic artery infusion or Intravenous infusion
    Patients with liver cirrhosis will be randomly divided into three groups. Umbilical cord MSCs will be infused to patients using interventional method via hepatic artery for one group. The catheter will be inserted to proper hepatic artery. After the catheter placement confirmed by angiography, umbilical cord MSCs will be infused slowly in 20-30 minutes. Umbilical cord MSCs will be infused intravenously slowly for 30-60 minutes in the intravenous infusion group. The control group will receive conserved therapy.
  • Active Comparator: Conserved Therapy
    Conserved Therapy
    Intervention: Drug: Conserved Therapy
  • Experimental: Interventional Therapy

    Patients with liver cirrhosis will be randomly divided into three groups.

    1. Umbilical cord MSCs will be infused to patients using interventional method via hepatic artery for one group.2. Umbilical cord MSCs will be infused to patients intravenously for another group. The control group will receive conserved therapy. The efficacy of different interventional therapies will be compared.

    Intervention: Procedure: Hepatic artery infusion or Intravenous infusion

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2015
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18-70 years.
  • Imaging evidences of liver cirrhosis.
  • Child-Plough score of 8 or more.
  • Model for End-Stage Liver Disease score of 20 or more.

Exclusion Criteria:

  • Liver tumor on ultrasonography, CT or MRI examination.
  • Problems in organs other than liver (e.g. heart or lungs).
  • History of moderate to severe hepatic encephalopathy or variceal bleeding.
  • Imaging evidences of vascular thromboses.
  • Coma.
Both
18 Years to 70 Years
No
Contact: Jianhe Gan, MD 86-0512-67780667 ganjianhe@yahoo.com
Contact: Yufang Shi, PhD, DVM 86-21-63848329 yufangshi@sibs.ac.cn
China
 
NCT01233102
SIBS-IHS-20101010, 2010CB945600
Yes
Yufang Shi,PhD., Institue of Health and Science, Chinese Academy of Sciences
Chinese Academy of Sciences
Soochow University
Principal Investigator: Yufang Shi, PhD,DVM Chinese Academy of Sciences
Study Chair: Jianhe Gan, MD The First Affiliated Hospital of Soochow University
Chinese Academy of Sciences
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP