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

NCT01728688 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2012-11-20

No results posted yet for this study

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.

Conditions

Interventions

OTHER

PBSC transplantation

PBSCs were mobilized with recombinant human G-CSF at 5-10ug/kg/d for three days. then PBSCs were collected by means of apheresis. The collected PBSCs were infused into participant via hepatic artery

OTHER

conventional treatment

Participants will receive conventional treatment and antiviral treatment.

Sponsors & Collaborators

  • The Second Affiliated Hospital of Chongqing Medical University

    collaborator OTHER

  • Eastern Hepatobiliary Surgery Hospital

    collaborator OTHER

  • Chinese Academy of Medical Sciences

    collaborator OTHER

  • Fudan University

    collaborator OTHER

  • Air Force Military Medical University, China

    lead OTHER

Principal Investigators

  • Daiming Fan · Air Force Military Medical University, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-09-30
Completion
2015-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01728688 on ClinicalTrials.gov