Umbilical Cord Blood Mononuclear Cells Therapy in Liver Cirrhosis

Study Overview
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Brief Summary
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This study is to evaluate the safety and efficacy of umbilical cord blood mononuclear cells transplantation in liver cirrhosis patients.

Detailed Description
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Decompensated liver cirrhosis (LC), a life-threatening complication of chronic liver disease, is one of the major indications for liver transplantation. Recently, umbilical cord blood mononuclear cells transfusion has been shown to lead to the regression of liver fibrosis in animal model. The investigators thus investigated the safety of the therapy with life signs like temperature, pulse, blood pressure, the incidence of hepatocellular carcinoma and mortality and so on. And the efficacy was evaluated with the measurement of alanine aminotransferase (ALT), glutamic oxaloacetic transaminase (AST), total bilirubin (TBIL), direct bilirubin (DBIL), albumin (ALB), cholinesterase (CHE), prothrombin time (PT) and child-pugh score.

Official Title
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Safety and Efficacy Investigation of Patients With Liver Cirrhosis by Transplantation of Umbilical Cord Blood Mononuclear Cells

Conditions
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Liver Cirrhosis

Intervention / Treatment
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* Biological: Umbilical Cord Blood Mononuclear Cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with hepatocirrhosis: according to the standard of child- pugh, liver functions to achieve class A or B patients, Including C class patients but can achieve B class after treatment Exclusion Criteria: Patients with C class by child-pugh score Patients in the acute phase of severe hepatitis Patients have been diagnosed with cancer of the liver Patients with severe cardiopulmonary cerebral disease, and in the failure state Patients in Highly allergic constitution Patients with moderately severe mental disease

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: umbilical cord blood mononuclear cells<br>Umbilical Cord blood come from healthy puerpera. Erythrocyte in umbilical cord blood was separated and deleted through sedimentation. Mononuclear cells in umbilical cord blood were then isolated with a conventional method and reagent,Ficoll,by density gradient centrifugation. | Biological: Umbilical Cord Blood Mononuclear Cells<br>* Participants will be transplanted with umbilical cord blood mononuclear cells.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| child-pugh classification | child-pugh A (child-pugh score 5-6) child-pugh B (child-pugh score 7-9) child-pugh C (child-pugh score≥10) | whinin 7 days before transplantation, 1,3 and 6 months after transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| coagulation | prothrombin time (PT) activated partial thromboplastin time (APTT) fibrinogen (FIB) | whinin 7 days before transplantation, 1,3,6 months after transplantation | 
| liver function | alanine aminotransferase (ALT) aspartate aminotransferase (AST) total bilirubin （TBIL） direct bilirubin (DBIL) serum cholinesterase (CHE) albumin (ALB) | whinin 7 days before transplantation, 1,3 and 6 months after transplantation | 
| vital signs | temperature pulse blood pressure | 1, 2 and 3 days after transplantation | 
| incidence of hepatocellular carcinoma |  | 1, 3 and 6 months after transplantation | 
| mortality |  | 1, 3 and 6 months after transplantation |