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Safety and Efficacy of Human Umbilical Cord Derived Mesenchymal Stem Cells for Treatment of HBV-related Liver Cirrhosis

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ClinicalTrials.gov Identifier: NCT01728727
Recruitment Status : Unknown
Verified November 2012 by Han Ying, Fourth Military Medical University.
Recruitment status was:  Recruiting
First Posted : November 20, 2012
Last Update Posted : November 20, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.

Mesenchymal stem cells (MSCs) possess plasticity and have the potential to differentiate into hepatocyte; Thus, MSCs hold great hope for therapeutic applications. Human umbilical cord-derived MSCs (hUC-MSCs) exhibit a more beneficial immunogenic profile and greater overall immunosuppressive potential than aged bone marrow-derived MSCs. Like MSCs derived from bone marrow, hUC-MSCs can also be used to treat rat liver fibrosis and improve glucose homeostasis in rats with liver cirrhosis. In this study, the patients with HBV-related liver cirrhosis will undergo administration of hUC-MSCs via hepatic artery to evaluate the safety and efficacy of hUC-MSC treatment for these patients.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis End Stage Liver Disease Other: UC-MSC transplantation Other: conventional treatment Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Human Umbilical Cord Derived Mesenchymal Stem Cells for Treatment of HBV-related Liver Cirrhosis
Study Start Date : September 2012
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: conventional
conventional treatment & antiviral treatment
Other: conventional treatment
Participants will receive conventional treatment and antiviral treatment.
Experimental: UC-MSC transplantation
Participants will receive umbilical cord derived mesenchymal stem cell treatment at day 1 and conventional treatment and antiviral treatment through the one year study visit. Participants will then be followed until one years study visit
Other: UC-MSC transplantation
After enrolled, Participant will receive umbilical cord MSC transplantation of 1*10E6 cells/kg via hepatic artery. Participant will then be followed until 1 years study visit

Outcome Measures

Primary Outcome Measures :
  1. one year survival rate [ Time Frame: one year after treatment ]

Secondary Outcome Measures :
  1. MELD score [ Time Frame: 1week, 4weeks,3months, 6months, 9months and 1year after treatment ]
  2. Child Pugh Score [ Time Frame: 1week, 4weeks,3months, 6months, 9months and 1year after treatment ]
  3. alpha fetoprotein [ Time Frame: 1week, 4weeks,3months, 6months, 9months and 1year after treatment ]
  4. renal function [ Time Frame: 1week, 4weeks,3months, 6months, 9months and 1year after treatment ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01728727

Contact: ying han 86-29-84771539 hanying@fmmu.edu.cn
Contact: yongquan shi 86-29-84771515 shiyquan@fmmu.edu.cn

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
Study Chair: Daiming Fan Fourth Military Medical University
More Information

Responsible Party: Han Ying, professor, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT01728727     History of Changes
Other Study ID Numbers: 20120912-3
First Posted: November 20, 2012    Key Record Dates
Last Update Posted: November 20, 2012
Last Verified: November 2012

Keywords provided by Han Ying, Fourth Military Medical University:
liver cirrhosis
end stage liver disease
umbilical cord
mesenchymal stem cells

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