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Mesenchymal Stem Cells Treat Liver Cirrhosis

Primary Purpose

Liver Cirrhosis

Status
Suspended
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Conserved Therapy
Hepatic artery infusion or Intravenous infusion
Sponsored by
Yufang Shi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis focused on measuring liver Cirrhosis, Mesenchymal stem cells, Hepatic artery infusion, Intravenous infusion

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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.

Sites / Locations

  • First Affiliated Hospital of Soochow University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conserved Therapy

Interventional Therapy

Arm Description

Conserved 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.

Outcomes

Primary Outcome Measures

The level of serum alanine aminotransferase (ALT）
The level of serum total bilirubin (TB)
The level of serum prothrombin time (PT)
The level of serum prealbumin(PA)
The level of serum albumin (ALB)
Overall survival

Secondary Outcome Measures

liver biopsy
Overall survival
The level of serum alanine aminotransferase (ALT）
The level of serum total bilirubin (TB)
The level of serum prothrombin time (PT)
The level of serum albumin (ALB)

Full Information

First Posted
October 25, 2010
Last Updated
February 19, 2016
Sponsor
Yufang Shi
Collaborators
Soochow University
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1. Study Identification

Unique Protocol Identification Number
NCT01233102
Brief Title
Mesenchymal Stem Cells Treat Liver Cirrhosis
Official Title
Umbilical Cord Mesenchymal Stem Cell Transfusion in Patients With Severe Liver Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Suspended
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yufang Shi
Collaborators
Soochow University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis
Keywords
liver Cirrhosis, Mesenchymal stem cells, Hepatic artery infusion, Intravenous infusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conserved Therapy
Arm Type
Active Comparator
Arm Description
Conserved Therapy
Arm Title
Interventional Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Conserved Therapy
Intervention Description
Conserved Therapy
Intervention Type
Procedure
Intervention Name(s)
Hepatic artery infusion or Intravenous infusion
Intervention 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 for 30-60 minutes in the intravenous infusion group. The control group will receive conserved therapy.
Primary Outcome Measure Information:
Title
The level of serum alanine aminotransferase (ALT）
Time Frame
1 year
Title
The level of serum total bilirubin (TB)
Time Frame
1 year
Title
The level of serum prothrombin time (PT)
Time Frame
1 year
Title
The level of serum prealbumin(PA)
Time Frame
1 year
Title
The level of serum albumin (ALB)
Time Frame
1 year
Title
Overall survival
Time Frame
1 year
Secondary Outcome Measure Information:
Title
liver biopsy
Time Frame
2 years
Title
Overall survival
Time Frame
2 years
Title
The level of serum alanine aminotransferase (ALT）
Time Frame
2 years
Title
The level of serum total bilirubin (TB)
Time Frame
2 years
Title
The level of serum prothrombin time (PT)
Time Frame
2 years
Title
The level of serum albumin (ALB)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yufang Shi, PhD,DVM
Organizational Affiliation
Chinese Academy of Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jianhe Gan, MD
Organizational Affiliation
The First Affiliated Hospital of Soochow University
Official's Role
Study Chair
Facility Information:
Facility Name
First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
18371435
Citation
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.
Results Reference
background
PubMed Identifier
16778155
Citation
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.
Results Reference
background
PubMed Identifier
19455046
Citation
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.
Results Reference
background
PubMed Identifier
19383405
Citation
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.
Results Reference
background
PubMed Identifier
17543295
Citation
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.
Results Reference
background
PubMed Identifier
19398237
Citation
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.
Results Reference
background
PubMed Identifier
20663626
Citation
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.
Results Reference
background
PubMed Identifier
20178458
Citation
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.
Results Reference
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Mesenchymal Stem Cells Treat Liver Cirrhosis

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