Safety and Efficacy of Human Bone Marrow 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:
NCT01724697
First received: October 31, 2012
Last updated: November 7, 2012
Last verified: November 2012

October 31, 2012
November 7, 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 NCT01724697 on ClinicalTrials.gov Archive Site
  • MELD score [ Time Frame: 1week, 4weeks, 3months, 6months, 9 months and 1year after treatment ] [ Designated as safety issue: Yes ]
  • AFP [ Time Frame: 1week, 4weeks, 3months, 6months, 9 months and 1year after treatment ] [ Designated as safety issue: Yes ]
  • renal function [ Time Frame: 1week, 4weeks, 3months, 6months, 9 months and 1year after treatment ] [ Designated as safety issue: Yes ]
  • child score [ Time Frame: 1week, 4weeks, 3months, 6months, 9 months and 1year after treatment ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Human Bone Marrow Stem Cells for Treatment of HBV-related Liver Cirrhosis
Safety and Efficacy of Human Autologous Bone Marrow 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.

stem cells(SCs) possess plasticity and have the potential to differentiate into hepatocyte; Thus, SCs hold great hope for therapeutic applications. Adult bone marrow is the most common source of SCs for clinical applications.Previous study showed that bone marrow derived stem cells (BMSCs) replace hepatocytes in injured liver, and effectively rescue experimental liver failure and contribute to liver regeneration. In this study, the patients with HBV-related liver cirrhosis will undergo administration of human autologous BMSCs via hepatic artery to evaluate the safty and efficacy of human autologous BMSCs 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: BMSC transplantation
    Patients randomized to the intervention arm will be collected for bone marrow stem cells and then infused with these cells via hepatic artery.
  • Other: conventional treatment & antivrial treatment
    Participants will recieve conventional treatment and antivrial treatment.
  • Active Comparator: conventional treatment
    conventional treatment & antivrial treatment.
    Intervention: Other: conventional treatment & antivrial treatment
  • Experimental: BMSC transplantation
    conventional treatment & antiviral treatment & autologous bone marrow stem cell transplantation via hepatic artery
    Intervention: Other: BMSC 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.theheart,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
China
 
NCT01724697
20120912-1
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