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SuspendedNCT01233102Updated Feb 22, 2016

Mesenchymal Stem Cells Treat Liver Cirrhosis

A Phase 1/2 interventional study of Conserved Therapy and Hepatic artery infusion or Intravenous infusion in Liver Cirrhosis, sponsored by Yufang Shi. Suspended at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-02-22.

Sponsored by Yufang Shi · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

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 in 30-60 minutes in the intravenous infusion group. The control group will receive conserved therapy. The levels of serum alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT), prealbumin(PA)and albumin (ALB) will be examined at re-transplantation, and 3 days to 2 years post-transplantation. The efficacy of umbilical cord MSCs transfusion will be investigated. The efficacy of different interventional therapies will also be compared.

02

Conditions studied

  • Liver Cirrhosis

Keywords

  • liver Cirrhosis
  • Mesenchymal stem cells
  • Hepatic artery infusion
  • Intravenous infusion
03

In context

Liver Cirrhosis

1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.

This study's planned enrollment of 200 is above the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

This is the only study on the registry with Yufang Shi as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
200 participants (estimated)

Study arms

  • Active comparator
    Conserved Therapy

    Conserved Therapy

    Drug: Conserved Therapy

  • Experimental
    Interventional Therapy

    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

  • DrugConserved Therapy

    Conserved Therapy

  • ProcedureHepatic artery infusion or Intravenous infusion

    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.

06

What researchers measure

Primary outcomes

  1. The level of serum alanine aminotransferase (ALT）

    Time frame: 1 year

  2. The level of serum total bilirubin (TB)

    Time frame: 1 year

  3. The level of serum prothrombin time (PT)

    Time frame: 1 year

  4. The level of serum prealbumin(PA)

    Time frame: 1 year

  5. The level of serum albumin (ALB)

    Time frame: 1 year

  6. Overall survival

    Time frame: 1 year

Secondary outcomes

  1. liver biopsy

    Time frame: 2 years

  2. Overall survival

    Time frame: 2 years

  3. The level of serum alanine aminotransferase (ALT）

    Time frame: 2 years

  4. The level of serum total bilirubin (TB)

    Time frame: 2 years

  5. The level of serum prothrombin time (PT)

    Time frame: 2 years

  6. The level of serum albumin (ALB)

    Time frame: 2 years

07

Study locations

1 site
  • First Affiliated Hospital of Soochow University
    Suzhou, Jiangsu 215006, China
08

References and documents

Publications

  • 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. PubMed 18371435 ↗
  • 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. PubMed 16778155 ↗
  • 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. PubMed 19455046 ↗
  • 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. PubMed 19383405 ↗
  • 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. PubMed 17543295 ↗
  • 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. Erratum In: J Hepatol. 2009 Nov;51(5):973. PubMed 19398237 ↗
  • 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. PubMed 20663626 ↗
  • 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. PubMed 20178458 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01233102
Lead sponsor
Yufang Shi
Collaborators
Soochow University
Responsible party
Yufang Shi (principal investigator, Chinese Academy of Sciences) — Sponsor-investigator
First posted
Nov 3, 2010
Start date
Oct 2009
Primary completion
Dec 2017 (estimated)
Completion
Dec 2019 (estimated)
Last update
Feb 22, 2016

Study contacts

Yufang Shi, PhD,DVM
principal investigator · Chinese Academy of Sciences
Jianhe Gan, MD
study chair · The First Affiliated Hospital of Soochow University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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