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

September 14, 2009 updated by: Sun Yat-sen University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Actual)

50

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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 Names:
  • interventional therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
pre-transplantation, and 3 days to 2 years post-transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

Third Affiliated Hospital, Sun Yat-Sen University

Investigators

  • Study Director: Zhu k shun, PHD, SunYat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ANTICIPATED)

December 1, 2009

Study Completion (ANTICIPATED)

June 1, 2010

Study Registration Dates

First Submitted

August 31, 2009

First Submitted That Met QC Criteria

September 11, 2009

First Posted (ESTIMATE)

September 14, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

September 15, 2009

Last Update Submitted That Met QC Criteria

September 14, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • zssy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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