Umbilical Cord Blood Mononuclear Cells Therapy in Liver Cirrhosis

Phase 1

• Conditions: Liver Cirrhosis
• Interventions: Biological: Umbilical Cord Blood Mononuclear Cells

• Registration Number: NCT01942915
• Lead Sponsor: Hebei Medical University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2013-09-06
• Study First Submitted QC: 2013-09-11
• Study First Posted: 2013-09-16
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-14
• Last Update Posted: 2013-11-15
• Primary Completion: 2013-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

1. Patients with C class by child-pugh score
2. Patients in the acute phase of severe hepatitis
3. Patients have been diagnosed with cancer of the liver
4. Patients with severe cardiopulmonary cerebral disease, and in the failure state
5. Patients in Highly allergic constitution
6. Patients with moderately severe mental disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
umbilical cord blood mononuclear cells	Umbilical Cord Blood Mononuclear Cells	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.

Primary Outcome Measures

Name	Time	Method
child-pugh classification	whinin 7 days before transplantation, 1,3 and 6 months after transplantation	1. child-pugh A (child-pugh score 5-6); 2. child-pugh B (child-pugh score 7-9); 3. child-pugh C (child-pugh score≥10)

Secondary Outcome Measures

Name	Time	Method
mortality	1, 3 and 6 months after transplantation
coagulation	whinin 7 days before transplantation, 1,3,6 months after transplantation	1. prothrombin time (PT); 2. activated partial thromboplastin time (APTT); 3. fibrinogen (FIB)
liver function	whinin 7 days before transplantation, 1,3 and 6 months after transplantation	1. alanine aminotransferase (ALT); 2. aspartate aminotransferase (AST); 3. total bilirubin （TBIL）; 4. direct bilirubin (DBIL); 5. serum cholinesterase (CHE); 6. albumin (ALB)
vital signs	1, 2 and 3 days after transplantation	1. temperature; 2. pulse; 3. blood pressure
incidence of hepatocellular carcinoma	1, 3 and 6 months after transplantation

Trial Locations

Locations (1)

the First Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China