Umbilical Cord Mesenchymal Stem Cell Transfusion in Patients With Severe Liver Cirrhosis
Overview
- Phase
- Phase 1
- Intervention
- Conserved Therapy
- Conditions
- Liver Cirrhosis
- Sponsor
- Yufang Shi
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- The level of serum total bilirubin (TB)
- Status
- Suspended
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
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.
Investigators
Yufang Shi
principal investigator
Chinese Academy of Sciences
Eligibility 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.
Arms & Interventions
Conserved Therapy
Conserved Therapy
Intervention: Conserved Therapy
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.
Intervention: Hepatic artery infusion or Intravenous infusion
Outcomes
Primary Outcomes
The level of serum total bilirubin (TB)
Time Frame: 1 year
Overall survival
Time Frame: 1 year
The level of serum prealbumin(PA)
Time Frame: 1 year
The level of serum alanine aminotransferase (ALT）
Time Frame: 1 year
The level of serum prothrombin time (PT)
Time Frame: 1 year
The level of serum albumin (ALB)
Time Frame: 1 year
Secondary Outcomes
- The level of serum prothrombin time (PT)(2 years)
- liver biopsy(2 years)
- Overall survival(2 years)
- The level of serum alanine aminotransferase (ALT）(2 years)
- The level of serum total bilirubin (TB)(2 years)
- The level of serum albumin (ALB)(2 years)