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Difference in Efficacy Between Stem Cell Transplantation and Classical Therapy in Liver Cirrhosis Patients

NCT ID: NCT01718587

Last Updated: 2012-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-07-31

Brief Summary

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The current treatment methods of liver cirrhosis are limited ,including antiviral therapy,supportive therapy and liver transplantation. Antiviral therapy and Supportive therapy especially the regularly intravenous infusions of plasma or albumin are combined in the clinical classical therapy treatment. In the other hand,umbilical cord mesenchyma stem cell with self and directed differentiation capacity can effectively rescue experimental liver failure and contribute to liver regeneration, which suggests the feasibility of stem cell transplantation therapy. In this study, the safety and efficacy of umbilical cord mesenchyma stem cell transplantation through interventional procedures and classical therapy in patients liver cirrhosis will be evaluated and compared.

Detailed Description

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This study will includ two research centers, the number of patients in transplantation group will be 30, the number of patients in classical therapy group will be 30. All the inclusion and exclusion criteria will be same and the data analysis will be complete by the epidemiological commissioner.

Conditions

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Liver Cirrhosis

Keywords

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umbilical cord mesenchyma stem cell liver cirrhosis antiviral therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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stem cell transplantation therapy

umbilical cord mesenchyma stem cell transplantation through interventional procedures do in liver cirrhosis patients.

Group Type EXPERIMENTAL

stem cell transplantation through interventional procedure

Intervention Type PROCEDURE

interventional procedure once

antiviral therapy

Antiviral therapy: lamivudine, 100 mg per day (oral dose); or adefovir dipivoxil 10 mg per day (oral dose); or grace entecavir 0.5-1mg per day (oral dose); or behalftelbivudine 600 mg per day (oral dose).

Supportive therapy are allowed to use on patients not including intravenous infusions of plasma or albumin.

Group Type ACTIVE_COMPARATOR

antiviral therapy (lamivudine, other antiviral drugs)

Intervention Type DRUG

lamivudine, 100 mg per day (oral dose); or adefovir dipivoxil 10 mg per day (oral dose); or grace entecavir 0.5-1mg per day (oral dose); or behalftelbivudine 600 mg per day (oral dose).

Interventions

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stem cell transplantation through interventional procedure

interventional procedure once

Intervention Type PROCEDURE

antiviral therapy (lamivudine, other antiviral drugs)

lamivudine, 100 mg per day (oral dose); or adefovir dipivoxil 10 mg per day (oral dose); or grace entecavir 0.5-1mg per day (oral dose); or behalftelbivudine 600 mg per day (oral dose).

Intervention Type DRUG

Other Intervention Names

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UCMSC transplantation lamivudine or other antiviral drugs.

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of liver cirrhosis;
* Without hepatic encephalopathy;
* No ascites or have easily dissipated ascites;
* Value of bilirubin is less than 100;
* Value of albumin is greater than 16 g / L;
* Prothrombin time is less than 21 seconds;

Exclusion Criteria

* Severe cardiovascular disease, and immunocompromised patients;
* Patients with localized lesions affecting graft infection;
* Coagulation disorders;
* Liver nodules more than 2cm or Liver cancer.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Hospital of Hebei Medical University

OTHER

Sponsor Role collaborator

General Hospital of Chinese Armed Police Forces

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yihua An, PhD

Role: STUDY_DIRECTOR

Department of Stem Cell Transplantation, the General Hospital of Chinese People's Armed Police Force

Locations

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Yihua An

Beijing, , China

Site Status

Countries

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China

Central Contacts

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Yihua An, PhD

Role: CONTACT

Phone: 0086-10-57976845

Email: [email protected]

Other Identifiers

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2012-10-09 TC liver cirrhosis

Identifier Type: -

Identifier Source: org_study_id