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

G

General Hospital of Chinese Armed Police Forces

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Liver Cirrhosis

Treatments

Drug: antiviral therapy (lamivudine, other antiviral drugs)
Procedure: stem cell transplantation through interventional procedure

Study type

Interventional

Funder types

Other

Identifiers

NCT01718587
2012-10-09 TC liver cirrhosis

Details and patient eligibility

About

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.

Full description

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

stem cell transplantation therapy
Experimental group
Description:
umbilical cord mesenchyma stem cell transplantation through interventional procedures do in liver cirrhosis patients.
Treatment:
Procedure: stem cell transplantation through interventional procedure
antiviral therapy
Active Comparator group
Description:
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.
Treatment:
Drug: antiviral therapy (lamivudine, other antiviral drugs)

Trial contacts and locations

1

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Central trial contact

Yihua An, PhD

Data sourced from clinicaltrials.gov

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