This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by Han Ying, Fourth Military Medical University.
Recruitment status was:  Recruiting
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 ]
Same as current
No Changes Posted
  • MELD score [ Time Frame: 1week, 4weeks,3months, 6months, 9months and 1year after treatment ]
  • Child Pugh Score [ Time Frame: 1week, 4weeks,3months, 6months, 9months and 1year after treatment ]
  • alpha fetoprotein [ Time Frame: 1week, 4weeks,3months, 6months, 9months and 1year after treatment ]
  • renal function [ Time Frame: 1week, 4weeks,3months, 6months, 9months and 1year after treatment ]
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
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.
 
Unknown status
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 -
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01728688
20120912-2
Yes
Not Provided
Not Provided
Not Provided
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 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