NCT01233102

Brief Summary

The purpose of this study is to investigate the efficacy of umbilical cord mesenchymal stem cells (MSCs) transfusion in the treatment of liver cirrhosis. Liver function will be monitored by serum analysis. The levels of serum alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT), prealbumin(PA) and albumin (ALB) will be examined at pre-transfusion, and 3 days to 2 years post-transfusion. Child-Pugh scores, Model for End-Stage Liver Disease scores and clinical symptoms will be assessed simultaneously.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
200

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2009

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
suspended

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

October 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2010

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 3, 2010

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 22, 2016

Status Verified

February 1, 2016

Enrollment Period

8.2 years

First QC Date

October 25, 2010

Last Update Submit

February 19, 2016

Conditions

Liver Cirrhosis

Keywords

liver CirrhosisMesenchymal stem cellsHepatic artery infusionIntravenous infusion

Outcome Measures

Primary Outcomes (6)

  • The level of serum alanine aminotransferase (ALT）

    1 year

  • The level of serum total bilirubin (TB)

    1 year

  • The level of serum prothrombin time (PT)

    1 year

  • The level of serum prealbumin(PA)

    1 year

  • The level of serum albumin (ALB)

    1 year

  • Overall survival

    1 year

Secondary Outcomes (6)

  • liver biopsy

    2 years

  • Overall survival

    2 years

  • The level of serum alanine aminotransferase (ALT）

    2 years

  • The level of serum total bilirubin (TB)

    2 years

  • The level of serum prothrombin time (PT)

    2 years

  • +1 more secondary outcomes

Study Arms (2)

Conserved Therapy

ACTIVE COMPARATOR

Conserved Therapy

Drug: Conserved Therapy

Interventional Therapy

EXPERIMENTAL

Patients with liver cirrhosis will be randomly divided into three groups. 1\. Umbilical cord MSCs will be infused to patients using interventional method via hepatic artery for one group.2. Umbilical cord MSCs will be infused to patients intravenously for another group. The control group will receive conserved therapy. The efficacy of different interventional therapies will be compared.

Procedure: Hepatic artery infusion or Intravenous infusion

Interventions

Conserved TherapyDRUG

Conserved Therapy

Conserved Therapy
Hepatic artery infusion or Intravenous infusionPROCEDURE

Patients with liver cirrhosis will be randomly divided into three groups. Umbilical cord MSCs will be infused to patients using interventional method via hepatic artery for one group. The catheter will be inserted to proper hepatic artery. After the catheter placement confirmed by angiography, umbilical cord MSCs will be infused slowly in 20-30 minutes. Umbilical cord MSCs will be infused intravenously slowly for 30-60 minutes in the intravenous infusion group. The control group will receive conserved therapy.

Interventional Therapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-70 years.
  • Imaging evidences of liver cirrhosis.
  • Child-Plough score of 8 or more.
  • Model for End-Stage Liver Disease score of 20 or more.

You may not qualify if:

  • Liver tumor on ultrasonography, CT or MRI examination.
  • Problems in organs other than liver (e.g. heart or lungs).
  • History of moderate to severe hepatic encephalopathy or variceal bleeding.
  • Imaging evidences of vascular thromboses.
  • Coma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

Related Publications (8)

  • Ren G, Zhang L, Zhao X, Xu G, Zhang Y, Roberts AI, Zhao RC, Shi Y. Mesenchymal stem cell-mediated immunosuppression occurs via concerted action of chemokines and nitric oxide. Cell Stem Cell. 2008 Feb 7;2(2):141-50. doi: 10.1016/j.stem.2007.11.014.

    PMID: 18371435BACKGROUND

  • Terai S, Ishikawa T, Omori K, Aoyama K, Marumoto Y, Urata Y, Yokoyama Y, Uchida K, Yamasaki T, Fujii Y, Okita K, Sakaida I. Improved liver function in patients with liver cirrhosis after autologous bone marrow cell infusion therapy. Stem Cells. 2006 Oct;24(10):2292-8. doi: 10.1634/stemcells.2005-0542. Epub 2006 Jun 15.

    PMID: 16778155BACKGROUND

  • 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

  • Dai LJ, Li HY, Guan LX, Ritchie G, Zhou JX. The therapeutic potential of bone marrow-derived mesenchymal stem cells on hepatic cirrhosis. Stem Cell Res. 2009 Jan;2(1):16-25. doi: 10.1016/j.scr.2008.07.005. Epub 2008 Aug 6.

    PMID: 19383405BACKGROUND

  • Abdel Aziz MT, Atta HM, Mahfouz S, Fouad HH, Roshdy NK, Ahmed HH, Rashed LA, Sabry D, Hassouna AA, Hasan NM. Therapeutic potential of bone marrow-derived mesenchymal stem cells on experimental liver fibrosis. Clin Biochem. 2007 Aug;40(12):893-9. doi: 10.1016/j.clinbiochem.2007.04.017. Epub 2007 May 3.

    PMID: 17543295BACKGROUND

  • Li C, Kong Y, Wang H, Wang S, Yu H, Liu X, Yang L, Jiang X, Li L, Li L. Homing of bone marrow mesenchymal stem cells mediated by sphingosine 1-phosphate contributes to liver fibrosis. J Hepatol. 2009 Jun;50(6):1174-83. doi: 10.1016/j.jhep.2009.01.028. Epub 2009 Mar 29.

    PMID: 19398237BACKGROUND

  • Kim TH, Kim JK, Shim W, Kim SY, Park TJ, Jung JY. Tracking of transplanted mesenchymal stem cells labeled with fluorescent magnetic nanoparticle in liver cirrhosis rat model with 3-T MRI. Magn Reson Imaging. 2010 Sep;28(7):1004-13. doi: 10.1016/j.mri.2010.03.047.

    PMID: 20663626BACKGROUND

  • Rabani V, Shahsavani M, Gharavi M, Piryaei A, Azhdari Z, Baharvand H. Mesenchymal stem cell infusion therapy in a carbon tetrachloride-induced liver fibrosis model affects matrix metalloproteinase expression. Cell Biol Int. 2010 Apr 27;34(6):601-5. doi: 10.1042/CBI20090386.

    PMID: 20178458BACKGROUND

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Infusions, Intravenous

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Administration, IntravenousDrug Administration RoutesDrug TherapyTherapeuticsInfusions, Parenteral

Study Officials

  • Yufang Shi, PhD,DVM

    Chinese Academy of Sciences

    PRINCIPAL INVESTIGATOR

  • Jianhe Gan, MD

    The First Affiliated Hospital of Soochow University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

October 25, 2010

First Posted

November 3, 2010

Study Start

October 1, 2009

Primary Completion

December 1, 2017

Study Completion

December 1, 2019

Last Updated

February 22, 2016

Record last verified: 2016-02

Locations

CN(1)