Overview

This trial is active, not recruiting.

Condition liver cirrhosis
Treatment umbilical cord blood mononuclear cells
Phase phase 1
Sponsor Hebei Medical University
Start date January 2012
End date December 2013
Trial size 10 participants
Trial identifier NCT01942915, 12276102D-Liver Cirrhosis

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
umbilical cord blood mononuclear cells
Participants will be transplanted with umbilical cord blood mononuclear cells.

Primary Outcomes

Measure
child-pugh classification
time frame: whinin 7 days before transplantation, 1,3 and 6 months after transplantation

Secondary Outcomes

Measure
coagulation
time frame: whinin 7 days before transplantation, 1,3,6 months after transplantation
liver function
time frame: whinin 7 days before transplantation, 1,3 and 6 months after transplantation
vital signs
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

Eligibility Criteria

Male or female participants from 20 years up to 80 years old.

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

Additional Information

Official title Safety and Efficacy Investigation of Patients With Liver Cirrhosis by Transplantation of Umbilical Cord Blood Mononuclear Cells
Principal investigator Sui Zhang, master
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by Hebei Medical University.