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Umbilical Cord Mesenchymal Stem Cells Infusion Via Hepatic Artery in Cirrhosis Patients

Primary Purpose

Liver Cirrhosis, Radiology, Mesenchymal Stem Cells

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
umbilical cord Mesenchymal Stem Cells
Conserved therapy
Sponsored by
Qingdao University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis focused on measuring Liver cirrhosis, Radiology, Mesenchymal Stem Cells, Umbilical Cord

Eligibility Criteria

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

Inclusion Criteria:

  • Aged 18~70 years.
  • Liver cirrhosis
  • written consent

Exclusion Criteria:

  • The end-stage of liver cirrhosis.
  • Severe problems in other vital organs(e.g.the heart,renal or lungs).
  • 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

Sites / Locations

  • Stem Cell Research Center of Medical School Hospital of Qingdao University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

umbilical cord mesenchymal stem cells

Conserved therapy

Arm Description

Umbilical cord mesenchymal stem cells were infused to patients using interventional method via hepatic artery. After the catheter placed at proper hepatic artery was confirmed by angiography,umbilical cord MSCs were infused slowly for 15-20minutes.

Patients received comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.

Outcomes

Primary Outcome Measures

The result of liver function and liver histological improvement.

Secondary Outcome Measures

The disappearance or reduction of abdominal dropsy
The clinical symptom improve(including food appetite,debilitation,abdominal distension,edema of lower limbs )

Full Information

First Posted
October 18, 2010
Last Updated
October 19, 2010
Sponsor
Qingdao University
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1. Study Identification

Unique Protocol Identification Number
NCT01224327
Brief Title
Umbilical Cord Mesenchymal Stem Cells Infusion Via Hepatic Artery in Cirrhosis Patients
Official Title
The Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion Via Hepatic Artery in Cirrhosis Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Qingdao 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) infusion via hepatic artery in the treatment of liver cirrhosis.
Detailed Description
To investigate the efficacy of umbilical cord mesenchymal stem cells (MSCs) infusion via hepatic artery in the treatment of liver cirrhosis. Patients with liver cirrhosis were randomly separated into two groups. Umbilical cord MSCs were infused to patients using interventional method via hepatic artery for One group. After the catheter placed at proper hepatic artery was confirmed by angiography, umbilical cord MSCs were infused slowly for 15-20minutes. The control group accepted conserved therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis, Radiology, Mesenchymal Stem Cells, Umbilical Cord
Keywords
Liver cirrhosis, Radiology, Mesenchymal Stem Cells, Umbilical Cord

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
umbilical cord mesenchymal stem cells
Arm Type
Experimental
Arm Description
Umbilical cord mesenchymal stem cells were infused to patients using interventional method via hepatic artery. After the catheter placed at proper hepatic artery was confirmed by angiography,umbilical cord MSCs were infused slowly for 15-20minutes.
Arm Title
Conserved therapy
Arm Type
Active Comparator
Arm Description
Patients received comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.
Intervention Type
Biological
Intervention Name(s)
umbilical cord Mesenchymal Stem Cells
Other Intervention Name(s)
Mesenchymal Stem Cells
Intervention Description
Umbilical cord mesenchymal stem cells were infused to patients using interventional method via hepatic artery. After the catheter placed at proper hepatic artery was confirmed by angiography,umbilical cord MSCs were infused slowly for 15-20minutes.
Intervention Type
Drug
Intervention Name(s)
Conserved therapy
Other Intervention Name(s)
Drug therapy
Intervention Description
Oral or intravenous administration
Primary Outcome Measure Information:
Title
The result of liver function and liver histological improvement.
Time Frame
every 4 weeks
Secondary Outcome Measure Information:
Title
The disappearance or reduction of abdominal dropsy
Time Frame
every 4 weeks
Title
The clinical symptom improve(including food appetite,debilitation,abdominal distension,edema of lower limbs )
Time Frame
every 4 weeks

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: Aged 18~70 years. Liver cirrhosis written consent Exclusion Criteria: The end-stage of liver cirrhosis. Severe problems in other vital organs(e.g.the heart,renal or lungs). 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianxia Hu, MD
Phone
86-0532-82911676
Email
qdyxyhjx@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hong Gao, MS
Phone
86-0532-82911676
Email
honggaogloria@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zibin Tian, MD
Organizational Affiliation
The Affiliated Hospital of Qingdao University
Official's Role
Study Director
Facility Information:
Facility Name
Stem Cell Research Center of Medical School Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266003
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianxia Hu, MD
Phone
86-0532-82911676
Email
qdyxyhjx@126.com
First Name & Middle Initial & Last Name & Degree
Hong Gao, MS
Phone
86-0532-82911676
Email
honggaogloria@gmail.com
First Name & Middle Initial & Last Name & Degree
Zibin Tian, MD

12. IPD Sharing Statement

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Umbilical Cord Mesenchymal Stem Cells Infusion Via Hepatic Artery in Cirrhosis Patients

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