Autologous Bone Marrow Mesenchymal Stem Cells Transplantation Via Hepatic Artery in Patients With Liver Cirrhosis
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Liver Cirrhosis
- Sponsor
- Sun Yat-sen University
- Enrollment
- 50
- Primary Endpoint
- The levels of serum alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT), albumin (ALB)
- Last Updated
- 16 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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