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Umbilical Cord Blood Mononuclear Cells Therapy in Liver Cirrhosis

Primary Purpose

Liver Cirrhosis

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Umbilical Cord Blood Mononuclear Cells
Sponsored by
Hebei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • the First Hospital of Hebei Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

umbilical cord blood mononuclear cells

Arm Description

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

coagulation
prothrombin time (PT) activated partial thromboplastin time (APTT) fibrinogen (FIB)
liver function
alanine aminotransferase (ALT) aspartate aminotransferase (AST) total bilirubin （TBIL） direct bilirubin (DBIL) serum cholinesterase (CHE) albumin (ALB)
vital signs
temperature pulse blood pressure
incidence of hepatocellular carcinoma
mortality

Full Information

First Posted
September 6, 2013
Last Updated
November 14, 2013
Sponsor
Hebei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01942915
Brief Title
Umbilical Cord Blood Mononuclear Cells Therapy in Liver Cirrhosis
Official Title
Safety and Efficacy Investigation of Patients With Liver Cirrhosis by Transplantation of Umbilical Cord Blood Mononuclear Cells
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hebei Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
umbilical cord blood mononuclear cells
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Umbilical Cord Blood Mononuclear Cells
Intervention Description
Participants will be transplanted with umbilical cord blood mononuclear cells.
Primary Outcome Measure Information:
Title
child-pugh classification
Description
child-pugh A (child-pugh score 5-6) child-pugh B (child-pugh score 7-9) child-pugh C (child-pugh score≥10)
Time Frame
whinin 7 days before transplantation, 1,3 and 6 months after transplantation
Secondary Outcome Measure Information:
Title
coagulation
Description
prothrombin time (PT) activated partial thromboplastin time (APTT) fibrinogen (FIB)
Time Frame
whinin 7 days before transplantation, 1,3,6 months after transplantation
Title
liver function
Description
alanine aminotransferase (ALT) aspartate aminotransferase (AST) total bilirubin （TBIL） direct bilirubin (DBIL) serum cholinesterase (CHE) albumin (ALB)
Time Frame
whinin 7 days before transplantation, 1,3 and 6 months after transplantation
Title
vital signs
Description
temperature pulse blood pressure
Time Frame
1, 2 and 3 days after transplantation
Title
incidence of hepatocellular carcinoma
Time Frame
1, 3 and 6 months after transplantation
Title
mortality
Time Frame
1, 3 and 6 months after transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baoyong Yan, doctor
Organizational Affiliation
The First Hospital of Hebei Medical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lixin Tong, master
Organizational Affiliation
The First Hospital of Hebei Medical University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sui Zhang, master
Organizational Affiliation
The First Hospital of Hebei Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Quanhai Li, doctor
Organizational Affiliation
The First Hospital of Hebei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
the First Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China

12. IPD Sharing Statement

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Umbilical Cord Blood Mononuclear Cells Therapy in Liver Cirrhosis

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