NCT01220492

Brief Summary

Liver cirrhosis (LC) represents a late stage of progressive hepatic fibrosis characterized by distortion of the hepatic architecture and formation of regenerative nodules. The liver transplantation is one of the only effective therapies available to such patients. However, lack of donors, surgical complications, rejection, and high cost are it's serious problems. The potential for stem cells to differentiate into hepatocytes cells was recently confirmed. Particularly, autologous bone marrow-derived mesenchymal stem cell (BM-MSC) has been demonstrated to decrease MELD score and increase serum albumin in the patients with decompensated liver cirrhosis. Therefore, the investigators propose a hypothesis that umbilical cord-derived MSCs (UC-MSC) can also improve the disease conditions of LC patients, particularly reducing the decompensated conditions in these patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
266

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2009

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2010

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 14, 2010

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

August 8, 2018

Status Verified

August 1, 2018

Enrollment Period

6.9 years

First QC Date

October 4, 2010

Last Update Submit

August 6, 2018

Conditions

Liver Cirrhosis

Keywords

liver cirrhosismesenchymal stem cellslonger term survivalsafety

Outcome Measures

Primary Outcomes (2)

  • survival time

    75 months

  • incidence of HCC events

    75 months

Secondary Outcomes (5)

  • The levels of serum albumin

    48 weeks

  • The levels of serum total bilirubin

    48 weeks

  • The levels of serum prothrombin activity

    48 weeks

  • the levels of serum cholinesterase

    48 weeks

  • complications

    48 weeks

Study Arms (2)

conventional plus MSC treatment

EXPERIMENTAL

participants will receive conventional treatment plus a dose of MSC from day 0 through the week 8 study visit. Participants will then be followed until the 75 months study visit.

Drug: conventional plus MSC treatment

conventional plus placebo treatment

EXPERIMENTAL

participants will receive conventional plus placebo treatment from day 0 through the week 8 study visit. Participants will then be followed until the 75 months study visit.

Drug: conventional plus placebo treatment

Interventions

conventional plus MSC treatmentDRUG

received conventional treatment and taken i.v., once per 4 week, at a dose of 0.5\*10E6 MSC/kg body for 8 weeks.

conventional plus MSC treatment
conventional plus placebo treatmentDRUG

received conventional treatment and taken i.v., once per 4 week, at 50 ml saline for 8 weeks.

conventional plus placebo treatment

Eligibility Criteria

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

You may qualify if:

  • Liver cirrhosis
  • Negative pregnancy test (female patients in fertile age)
  • written consent

You may not qualify if:

  • Hepatocellular carcinoma or other malignancies
  • Pregnancy
  • sepsis
  • Presence of significant extrahepatic biliary disease (e.g. CBD stone, PSC, etc.)
  • Cardiac, renal or respiratory failure
  • Active thrombosis of the portal or hepatic veins

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing 302 Hospital

Beijing, Beijing Municipality, 100039, China

Location

Related Publications (4)

  • Schuppan D, Afdhal NH. Liver cirrhosis. Lancet. 2008 Mar 8;371(9615):838-51. doi: 10.1016/S0140-6736(08)60383-9.

    PMID: 18328931BACKGROUND

  • Kisseleva T, Gigante E, Brenner DA. Recent advances in liver stem cell therapy. Curr Opin Gastroenterol. 2010 Jul;26(4):395-402. doi: 10.1097/MOG.0b013e32833a6bec.

    PMID: 20495456BACKGROUND

  • Kharaziha P, Hellstrom PM, Noorinayer B, Farzaneh F, Aghajani K, Jafari F, Telkabadi M, Atashi A, Honardoost M, Zali MR, Soleimani M. Improvement of liver function in liver cirrhosis patients after autologous mesenchymal stem cell injection: a phase I-II clinical trial. Eur J Gastroenterol Hepatol. 2009 Oct;21(10):1199-205. doi: 10.1097/MEG.0b013e32832a1f6c.

    PMID: 19455046BACKGROUND

  • Mohamadnejad M, Alimoghaddam K, Mohyeddin-Bonab M, Bagheri M, Bashtar M, Ghanaati H, Baharvand H, Ghavamzadeh A, Malekzadeh R. Phase 1 trial of autologous bone marrow mesenchymal stem cell transplantation in patients with decompensated liver cirrhosis. Arch Iran Med. 2007 Oct;10(4):459-66.

    PMID: 17903050RESULT

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Officials

  • Fu-Sheng Wang, Professor

    Beijing 302 Hospital

    PRINCIPAL INVESTIGATOR

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
the Institute of Translational hepatology

Study Record Dates

First Submitted

October 4, 2010

First Posted

October 14, 2010

Study Start

May 1, 2009

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

August 8, 2018

Record last verified: 2018-08

Locations

CN(1)