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

Phase 2

• Conditions: Liver Cirrhosis
• Interventions: Procedure: Conserved Therapy; Procedure: Hepatic artery infusion

• Registration Number: NCT00976287
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-01
• Study First Submitted: 2009-08-31
• Status Verified: 2009-09
• Study First Submitted QC: 2009-09-11
• Study First Posted: 2009-09-14
• Last Update Submitted: 2009-09-14
• Last Update Posted: 2009-09-15
• Primary Completion: 2009-12
• Study Completion: 2010-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conserved Therapy	Conserved Therapy	Conserved Therapy
Interventional Therapy	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.

Primary Outcome Measures

Name	Time	Method
The levels of serum alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT), albumin (ALB)	pre-transplantation, and 3 days to 2 years post-transplantation