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Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV-related Liver Cirrhosis

Liver Cirrhosis Clinical Trial

Official title:
Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV-related Liver Cirrhosis

Clinical Trial Summary

HBV related Liver disease is a common medical problem in China. An estimated 7.18% of the Chinese (about 93 million) is infected with hepatitis B, and most of the HBV- related hepatitis can developed into liver cirrhosis.

Liver transplantation is the only available life saving treatment for patients with end stage liver disease. However, lack of donors, surgical complications, rejection, and high cost are serious problems.

In preclinical studies the investigators have demonstrated that G-CSF mobilized PBSC from patients with HBV related liver cirrhosis could differentiate into functional hepatocyte and autologous PBSC transplantation can significantly improve liver synthetic function. But further studied was needed to confirm the safety and efficacy of PBSC transplantation. In this study, a prospective, randomized, parallel clinical study was designed. The patients with HBV-related liver cirrhosis will undergo administration of human autologous PBSCs via hepatic artery to evaluate the safety and efficacy of human autologous PBSCs treatment for these patients.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01728688
Study type Interventional
Source Fourth Military Medical University
Contact Ying Han
Phone 86-29-84771539
Email hanying@fmmu.edu.cn
Status Recruiting
Phase Phase 1/Phase 2
Start date September 2012
Completion date September 2015
View Details
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