Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Safety and Efficacy of Human Umbilical Cord Derived Mesenchymal 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 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:
NCT01728727
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 ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Human Umbilical Cord Derived Mesenchymal Stem Cells for Treatment of HBV-related Liver Cirrhosis
Safety and Efficacy of Human Umbilical Cord Derived Mesenchymal 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.

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.

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: 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
  • Other: conventional treatment
    Participants will receive conventional treatment and antiviral treatment.
  • Active Comparator: conventional
    conventional treatment & antiviral treatment
    Intervention: Other: conventional 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
    Intervention: Other: UC-MSC 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
Both
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01728727
20120912-3
Yes
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