NCT01718587

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: General Hospital of Chinese Armed Police Forces · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Liver Cirrhosis

Interventions

Type	Name	Description
PROCEDURE	stem cell transplantation through interventional procedure	interventional procedure once
DRUG	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).

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-05-01
• Completion: 2014-07-01
• First posted: 2012-10-31
• Last updated: 2012-10-31

Locations

1 site across 1 country: China