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

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.


Condition Intervention Phase
Liver Cirrhosis
End Stage Liver Disease
 Other: BMSC transplantation
Other: conventional treatment & antivrial 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 Bone Marrow 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, 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 ]

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 treatment
conventional treatment & antivrial treatment.
 Other: conventional treatment & antivrial treatment
Participants will recieve conventional treatment and antivrial treatment.
Experimental: BMSC transplantation
conventional treatment & antiviral treatment & autologous bone marrow stem cell transplantation via hepatic artery
 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.

  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.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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01724697

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: NCT01724697     History of Changes
Other Study ID Numbers: 20120912-1
Study First Received: October 31, 2012
Last Updated: November 7, 2012
Health Authority: China:The Ministray of Science and Technology

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

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 16, 2013