Umbilical Cord Blood Mononuclear Cells Therapy in Liver Cirrhosis

Phase 1UnknownNCT01942915

Hebei Medical University10 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Liver Cirrhosis

Interventions

Umbilical Cord Blood Mononuclear CellsBIOLOGICAL

Participants will be transplanted with umbilical cord blood mononuclear cells.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

the First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Outcomes

Primary Outcomes

child-pugh classification

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)

Time frame: whinin 7 days before transplantation, 1,3 and 6 months after transplantation

Secondary Outcomes

coagulation

1. prothrombin time (PT) 2. activated partial thromboplastin time (APTT) 3. fibrinogen (FIB)

Time frame: whinin 7 days before transplantation, 1,3,6 months after transplantation

liver function

1. alanine aminotransferase (ALT) 2. aspartate aminotransferase (AST) 3. total bilirubin （TBIL） 4. direct bilirubin (DBIL) 5. serum cholinesterase (CHE) 6. albumin (ALB)

Time frame: whinin 7 days before transplantation, 1,3 and 6 months after transplantation

vital signs

1. temperature 2. pulse 3. blood pressure

Time frame: 1, 2 and 3 days after transplantation

incidence of hepatocellular carcinoma

Time frame: 1, 3 and 6 months after transplantation

mortality

Time frame: 1, 3 and 6 months after transplantation

Data from ClinicalTrials.gov

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