Umbilical Cord Blood Mononuclear Cells Therapy in Liver Cirrhosis

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

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

Study Overview

• Status: Unknown
• Conditions: Liver Cirrhosis
• Intervention / Treatment: Biological: Umbilical Cord Blood Mononuclear Cells

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 Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • The First Hospital of Hebei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Biological: Umbilical Cord Blood Mononuclear Cells; Participants will be transplanted with umbilical cord blood mononuclear cells.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hebei Medical University
• Investigators: Study Director: Lixin Tong, master, The First Hospital of Hebei Medical University; Principal Investigator: Sui Zhang, master, The First Hospital of Hebei Medical University; Principal Investigator: Quanhai Li, doctor, The First Hospital of Hebei Medical University

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: September 6, 2013
• First Submitted That Met QC Criteria: September 11, 2013
• First Posted (Estimate): September 16, 2013

Study Record Updates

• Last Update Posted (Estimate): November 15, 2013
• Last Update Submitted That Met QC Criteria: November 14, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: 12276102D-Liver Cirrhosis