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

This study is currently recruiting participants. (see Contacts and Locations)
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

October 31, 2012
November 13, 2012
September 2012
September 2014   (final data collection date for primary outcome measure)
one-year survival rate [ Time Frame: one year after treatment ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01728688 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV-related Liver Cirrhosis
Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV-related Liver Cirrhosis

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Liver Cirrhosis
  • End Stage Liver Disease
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
September 2015
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Aged 18-65 years
  2. HBV-related liver cirrhosis
  3. Child-Pugh score 9-15
  4. Written consent

Exclusion Criteria:

  1. Hepatocellular carcinoma or other malignancies
  2. Severe problems in other vital organs(e.g.the heart,renal or lungs)
  3. Pregnant or lactating women
  4. Severe bacteria infection
  5. Anticipated with difficulty of follow-up observation
  6. Other candidates who are judged to be not applicable to this study by doctors -
Both
18 Years to 65 Years
No
Contact: Ying Han 86-29-84771539 hanying@fmmu.edu.cn
Contact: Yongquan Shi 86-29-84771515 shiyquan@fmmu.edu.cn
China
 
NCT01728688
20120912-2
Yes
Han Ying, Fourth Military Medical University
Fourth Military Medical University
  • The Second Affiliated Hospital of Chongqing Medical University
  • Eastern Hepatobiliary Surgery Hospital
  • Chinese Academy of Medical Sciences
  • Fudan University
Study Chair: Daiming Fan The Fourth Military Medical University
Fourth Military Medical University
November 2012

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