NCT01724697

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. 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.

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
12 days until next milestone

First Posted

Study publicly available on registry

November 12, 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 12, 2012

Status Verified

November 1, 2012

Enrollment Period

2 years

First QC Date

October 31, 2012

Last Update Submit

November 7, 2012

Conditions

Liver CirrhosisEnd Stage Liver Disease

Keywords

liver cirrhosisend stage liver diseaseHBVautologousstem cellbone morrow

Outcome Measures

Primary Outcomes (1)

  • one year survival rate

    one year after treatment

Secondary Outcomes (4)

  • MELD score

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

  • AFP

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

  • renal function

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

  • child score

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

Study Arms (2)

conventional treatment

ACTIVE COMPARATOR

conventional treatment \& antivrial treatment.

Other: conventional treatment & antivrial treatment

BMSC transplantation

EXPERIMENTAL

conventional treatment \& antiviral treatment \& autologous bone marrow stem cell transplantation via hepatic artery

Other: BMSC transplantation

Interventions

BMSC transplantationOTHER

Patients randomized to the intervention arm will be collected for bone marrow stem cells and then infused with these cells via hepatic artery.

BMSC transplantation
conventional treatment & antivrial treatmentOTHER

Participants will recieve conventional treatment and antivrial treatment.

conventional treatment

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.theheart,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

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 12, 2012

Study Start

September 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2015

Last Updated

November 12, 2012

Record last verified: 2012-11

Locations

CN(1)