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

This study is currently recruiting participants.

Verified November 2012 by Fourth Military Medical University

Sponsor:

Collaborators:

The Second Affiliated Hospital of Chongqing Medical University

Eastern Hepatobiliary Surgery Hospital

Chinese Academy of Medical Sciences

Fudan University

Information provided by (Responsible Party):

Han Ying, Fourth Military Medical University

ClinicalTrials.gov Identifier:

NCT01728688

First received: October 31, 2012

Last updated: November 13, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

October 31, 2012

Last Updated Date

November 13, 2012

Start Date ^ICMJE

September 2012

Estimated Primary Completion Date

September 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

one-year survival rate [ Time Frame: one year after treatment ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01728688 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

MELD score [ Time Frame: 1week, 4weeks,3months, 6months, 9months and 1year after treatment ] [ Designated as safety issue: Yes ]
Child Pugh Score [ Time Frame: 1week, 4weeks,3months, 6months, 9months and 1year after treatment ] [ Designated as safety issue: Yes ]
alpha fetoprotein [ Time Frame: 1week, 4weeks,3months, 6months, 9months and 1year after treatment ] [ Designated as safety issue: Yes ]
renal function [ Time Frame: 1week, 4weeks,3months, 6months, 9months and 1year after treatment ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Liver Cirrhosis
End Stage Liver Disease

Intervention ^ICMJE

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.

Study Arm (s)

Active Comparator: Conventional
conventional treatment & antiviral treatment

Intervention: Other: conventional treatment
Experimental: conventional & PBSC transplantation
After three days G-CSF mobilization, Patients randomized to the intervention arm will receive autologous PBSCs transplantation at day1, and receive conventional treatment and antiviral treatment through the one year study visit and followed until one years study visit.

Intervention: Other: PBSC transplantation

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

240

Estimated Completion Date

September 2015

Estimated Primary Completion Date

September 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Aged 18-65 years
HBV-related liver cirrhosis
Child-Pugh score 9-15
Written consent

Exclusion Criteria:

Hepatocellular carcinoma or other malignancies
Severe problems in other vital organs(e.g.the heart,renal or lungs)
Pregnant or lactating women
Severe bacteria infection
Anticipated with difficulty of follow-up observation
Other candidates who are judged to be not applicable to this study by doctors -

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Ying Han	86-29-84771539	hanying@fmmu.edu.cn
Contact: Yongquan Shi	86-29-84771515	shiyquan@fmmu.edu.cn

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01728688

Other Study ID Numbers ^ICMJE

20120912-2

Has Data Monitoring Committee

Yes

Responsible Party

Han Ying, Fourth Military Medical University

Study Sponsor ^ICMJE

Fourth Military Medical University

Collaborators ^ICMJE

The Second Affiliated Hospital of Chongqing Medical University
Eastern Hepatobiliary Surgery Hospital
Chinese Academy of Medical Sciences
Fudan University

Investigators ^ICMJE

Study Chair:

Daiming Fan

The Fourth Military Medical University

Information Provided By

Fourth Military Medical University

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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