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Safety and Efficacy of Stem Cell Transplantation for Treatment of Liver Cirrhosis

NCT ID: NCT01491165

Last Updated: 2012-10-26

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

PHASE2/PHASE3

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2014-06-30

Brief Summary

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Mainstream of current treatment of liver cirrhosis is liver transplantation, but there are high cost, risk and immune rejection and other issues. 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 in patients liver cirrhosis will be evaluated.

Detailed Description

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This study included three research centers, each center were carried out 25 cases of liver cirrhosis in patients with stem cell transplantation. All the selection and exclusion criteria are same, data summary and analysis will be complete by the epidemiological commissioner.

Conditions

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Other Surgical Procedures

Keywords

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umbilical cord mesenchyma stem cell

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 procedures

Intervention Type PROCEDURE

one time interventional procedures

Interventions

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stem cell transplantation through interventional procedures

one time interventional procedures

Intervention Type PROCEDURE

Other Intervention Names

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umbilical cord mesenchyma stem cell transplantation

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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Xinjiang Armed Police Corps Hospital

UNKNOWN

Sponsor Role collaborator

Taian Hospital of Traditional Chinese Medicine

UNKNOWN

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

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 RECRUITING

Countries

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China

Facility Contacts

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Yihua An, doctor

Role: primary

Other Identifiers

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2011-12-07 liver cirrhosis

Identifier Type: -

Identifier Source: org_study_id