Mesenchymal Stem Cells Treat Liver Cirrhosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Umbilical Cord Mesenchymal Stem Cell Transfusion in Patients With Severe Liver Cirrhosis

Conditions
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Liver Cirrhosis

Intervention / Treatment
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* Drug: Conserved Therapy
* Procedure: Hepatic artery infusion or Intravenous infusion


Participation Criteria
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Eligibility Criteria
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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. Coma.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conserved Therapy<br>Conserved Therapy | Drug: Conserved Therapy<br>* Conserved Therapy<br>|
| Experimental: Interventional Therapy<br>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. | Procedure: Hepatic artery infusion or Intravenous infusion<br>* 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 for 30-60 minutes in the intravenous infusion group. The control group will receive conserved therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The level of serum alanine aminotransferase (ALT） |  | 1 year | 
| The level of serum total bilirubin (TB) |  | 1 year | 
| The level of serum prothrombin time (PT) |  | 1 year | 
| The level of serum prealbumin(PA) |  | 1 year | 
| The level of serum albumin (ALB) |  | 1 year | 
| Overall survival |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 prothrombin time (PT) |  | 2 years | 
| The level of serum albumin (ALB) |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver Cirrhosis, Mesenchymal stem cells, Hepatic artery infusion, Intravenous infusion