NCT01728727

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2012

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2012

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 20, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

November 20, 2012

Status Verified

November 1, 2012

Enrollment Period

2 years

First QC Date

October 31, 2012

Last Update Submit

November 13, 2012

Conditions

Liver CirrhosisEnd Stage Liver Disease

Keywords

liver cirrhosisend stage liver diseaseumbilical cordmesenchymal stem cellsHBV

Outcome Measures

Primary Outcomes (1)

  • one year survival rate

    one year after treatment

Secondary Outcomes (4)

  • MELD score

    1week, 4weeks,3months, 6months, 9months and 1year after treatment

  • Child Pugh Score

    1week, 4weeks,3months, 6months, 9months and 1year after treatment

  • alpha fetoprotein

    1week, 4weeks,3months, 6months, 9months and 1year after treatment

  • renal function

    1week, 4weeks,3months, 6months, 9months and 1year after treatment

Study Arms (2)

conventional

ACTIVE COMPARATOR

conventional treatment \& antiviral treatment

Other: conventional treatment

UC-MSC transplantation

EXPERIMENTAL

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

Interventions

UC-MSC transplantationOTHER

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

UC-MSC transplantation
conventional treatmentOTHER

Participants will receive conventional treatment and antiviral treatment.

conventional

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital of Digestive Disease

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Liver CirrhosisEnd Stage Liver Disease

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsLiver FailureHepatic Insufficiency

Study Officials

  • Daiming Fan

    Air Force Military Medical University, China

    STUDY CHAIR

Central Study Contacts

ying han

CONTACT

86-29-84771539hanying@fmmu.edu.cn

yongquan shi

CONTACT

86-29-84771515shiyquan@fmmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

October 31, 2012

First Posted

November 20, 2012

Study Start

September 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2015

Last Updated

November 20, 2012

Record last verified: 2012-11

Locations

CN(1)