Overview

This trial is active, not recruiting.

Condition liver cirrhosis
Treatments hepatic artery infusion, conserved therapy
Phase phase 2
Sponsor Sun Yat-sen University
Collaborator Third Affiliated Hospital, Sun Yat-Sen University
Start date January 2008
End date December 2009
Trial size 50 participants
Trial identifier NCT00976287, zssy

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
Conserved Therapy
conserved therapy interventional
Conserved Therapy
(Experimental)
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.
hepatic artery infusion 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.

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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.

Additional Information

Official title Autologous Bone Marrow Mesenchymal Stem Cells Transplantation Via Hepatic Artery in Patients With Liver Cirrhosis
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2009.
Information provided to ClinicalTrials.gov by Sun Yat-sen University.