Safety and Efficacy of Human Umbilical Cord Derived Mesenchymal 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:

NCT01728727

First received: October 31, 2012

Last updated: November 13, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

October 31, 2012

Last Updated Date

November 13, 2012

Start Date ^ICMJE

September 2012

Estimated Primary Completion Date

September 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

one year survival rate [ Time Frame: one year after treatment ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01728727 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Liver Cirrhosis
End Stage Liver Disease

Intervention ^ICMJE

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.

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

240

Estimated Completion Date

September 2015

Estimated Primary Completion Date

September 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Aged 18-65 years
HBV-related liver cirrhosis
Child-Pugh score 9-15
Written consent -

Exclusion Criteria:

Hepatocellular carcinoma or other malignancies
Severe problems in other vital organs(e.g.the heart,renal or lungs)
Pregnant or lactating women
Severe bacteria infection
Anticipated with difficulty of follow-up observation
Other candidates who are judged to be not applicable to this study by doctors

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01728727

Other Study ID Numbers ^ICMJE

20120912-3

Has Data Monitoring Committee

Yes

Responsible Party

Han Ying, Fourth Military Medical University

Study Sponsor ^ICMJE

Fourth Military Medical University

Collaborators ^ICMJE

The Second Affiliated Hospital of Chongqing Medical University
Eastern Hepatobiliary Surgery Hospital
Chinese Academy of Medical Sciences
Fudan University

Investigators ^ICMJE

Study Chair:

Daiming Fan

The Fourth Military Medical University

Information Provided By

Fourth Military Medical University

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top