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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
  Purpose

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.


Condition Intervention Phase
Liver Cirrhosis
End Stage Liver Disease
 Other: PBSC transplantation
Other: conventional treatment
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV-related Liver Cirrhosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fourth Military Medical University:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 240
Study Start Date: September 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional
conventional treatment & antiviral treatment
 Other: conventional treatment
Participants will receive conventional treatment and antiviral 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.
 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01728688

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

Locations
China, Shaanxi
Xijing Hospital of Digestive Disease Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Ying Han     86-29-84771539     hanying@fmmu.edu.cn    
Contact: Yongquan Shi     86-29-84771515     shiyquan@fmmu.edu.cn    
Sponsors and Collaborators
Fourth Military Medical University
The Second Affiliated Hospital of Chongqing Medical University
Eastern Hepatobiliary Surgery Hospital
Chinese Academy of Medical Sciences
Fudan University
Investigators
Study Chair: Daiming Fan The Fourth Military Medical University
  More Information

No publications provided

Responsible Party: Han Ying, professor, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT01728688     History of Changes
Other Study ID Numbers: 20120912-2
Study First Received: October 31, 2012
Last Updated: November 13, 2012
Health Authority: China: Ministry of Science and Technology

Keywords provided by Fourth Military Medical University:
liver cirrhosis
stem cell
peripheral blood
 autologous
HBV
end stage liver disease

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Liver Diseases
End Stage Liver Disease
 Digestive System Diseases
Pathologic Processes
Liver Failure
Hepatic Insufficiency

ClinicalTrials.gov processed this record on May 19, 2013