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
  Purpose

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.


Condition Intervention Phase
Liver Cirrhosis
Drug: Conserved Therapy
Procedure: Hepatic artery infusion or Intravenous infusion
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Umbilical Cord Mesenchymal Stem Cell Transfusion in Patients With Severe Liver Cirrhosis

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Sciences:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: October 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conserved Therapy
Conserved Therapy
Drug: Conserved Therapy
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.

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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01233102

Contacts
Contact: Jianhe Gan, MD 86-0512-67780667 ganjianhe@yahoo.com
Contact: Yufang Shi, PhD, DVM 86-21-63848329 yufangshi@sibs.ac.cn

Locations
China, Jiangsu
First Affiliated Hospital of Soochow University Recruiting
Suzhou, Jiangsu, China, 215006
Contact: Jianhe Gan, MD         
Sponsors and Collaborators
Chinese Academy of Sciences
Soochow University
Investigators
Principal Investigator: Yufang Shi, PhD,DVM Chinese Academy of Sciences
Study Chair: Jianhe Gan, MD The First Affiliated Hospital of Soochow University
  More Information

Publications:

Responsible Party: Yufang Shi,PhD., Institue of Health and Science, Chinese Academy of Sciences
ClinicalTrials.gov Identifier: NCT01233102     History of Changes
Other Study ID Numbers: SIBS-IHS-20101010, 2010CB945600
Study First Received: October 25, 2010
Last Updated: November 2, 2010
Health Authority: China: Ministry of Health

Keywords provided by Chinese Academy of Sciences:
liver Cirrhosis
Mesenchymal stem cells
Hepatic artery infusion
Intravenous infusion

Additional relevant MeSH terms:
Liver Cirrhosis
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on October 23, 2014