Difference in Efficacy Between Stem Cell Transplantation and Classical Therapy in Liver Cirrhosis Patients
Primary Purpose
Liver Cirrhosis
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
stem cell transplantation through interventional procedure
antiviral therapy (lamivudine, other antiviral drugs)
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cirrhosis focused on measuring umbilical cord mesenchyma stem cell, liver cirrhosis, antiviral therapy
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of liver cirrhosis;
- Without hepatic encephalopathy;
- No ascites or have easily dissipated ascites;
- Value of bilirubin is less than 100;
- Value of albumin is greater than 16 g / L;
- Prothrombin time is less than 21 seconds;
Exclusion Criteria:
- Severe cardiovascular disease, and immunocompromised patients;
- Patients with localized lesions affecting graft infection;
- Coagulation disorders;
- Liver nodules more than 2cm or Liver cancer.
Sites / Locations
- Yihua An
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
stem cell transplantation therapy
antiviral therapy
Arm Description
umbilical cord mesenchyma stem cell transplantation through interventional procedures do in liver cirrhosis patients.
Antiviral therapy: lamivudine, 100 mg per day (oral dose); or adefovir dipivoxil 10 mg per day (oral dose); or grace entecavir 0.5-1mg per day (oral dose); or behalftelbivudine 600 mg per day (oral dose). Supportive therapy are allowed to use on patients not including intravenous infusions of plasma or albumin.
Outcomes
Primary Outcome Measures
liver volume calculated by MRI
Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.
change from baseline in liver volume calculated by MRI at 6 months
Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.
change from baseline in liver volume calculated by MRI at 12 months
Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.
Secondary Outcome Measures
blood biochemistry
alanine aminotransferase
aspartate aminotransferase
gamma-glutamyltransferase(GGT)
alkaline phosphatase
total bilirubin
direct bilirubin
The total bile acid (TBA)
albumin
the proportion of white balls
blood test
platelet count (PLT)
mean platelet volume (MPV)
platelet distribution width (PDW)
platelet hematocrit (PCT)
alpha feto protein (AFP)
liver enzyme fiber spectrum
laminin (LN)
Ⅳ collagen detection (CIV)
hyaluronic acid (HA)
procollagen Ⅲ(PC Ⅲ)
coagulation
prothrombin time (PT)
activated partial thromboplastin time (APTT)
fibrinogen (FIB)
thrombin time (TT)
portal vein and splenic vein measure
1)Portal vein diameter (Dpv) 2)Portal vein maximum velocity (Vmaxpv) 3)Portal vein blood flow per minute (Qpv) 4) The splenic vein diameter (Dsv) 5) Splenic vein maximum flow velocity (Vmaxsv) 6) Splenic vein blood flow per minute (Qsv)
estrogen and progestin in blood
estrogen and progestin
Full Information
NCT ID
NCT01718587
First Posted
October 25, 2012
Last Updated
October 30, 2012
Sponsor
General Hospital of Chinese Armed Police Forces
Collaborators
The First Hospital of Hebei Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01718587
Brief Title
Difference in Efficacy Between Stem Cell Transplantation and Classical Therapy in Liver Cirrhosis Patients
Official Title
Difference in Efficacy Between Umbilical Cord Mesenchyma Stem Cell Transplantation and Classical Therapy in Liver Cirrhosis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
July 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
General Hospital of Chinese Armed Police Forces
Collaborators
The First Hospital of Hebei Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The current treatment methods of liver cirrhosis are limited ,including antiviral therapy,supportive therapy and liver transplantation. Antiviral therapy and Supportive therapy especially the regularly intravenous infusions of plasma or albumin are combined in the clinical classical therapy treatment. In the other hand,umbilical cord mesenchyma stem cell with self and directed differentiation capacity can effectively rescue experimental liver failure and contribute to liver regeneration, which suggests the feasibility of stem cell transplantation therapy. In this study, the safety and efficacy of umbilical cord mesenchyma stem cell transplantation through interventional procedures and classical therapy in patients liver cirrhosis will be evaluated and compared.
Detailed Description
This study will includ two research centers, the number of patients in transplantation group will be 30, the number of patients in classical therapy group will be 30. All the inclusion and exclusion criteria will be same and the data analysis will be complete by the epidemiological commissioner.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis
Keywords
umbilical cord mesenchyma stem cell, liver cirrhosis, antiviral therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
stem cell transplantation therapy
Arm Type
Experimental
Arm Description
umbilical cord mesenchyma stem cell transplantation through interventional procedures do in liver cirrhosis patients.
Arm Title
antiviral therapy
Arm Type
Active Comparator
Arm Description
Antiviral therapy: lamivudine, 100 mg per day (oral dose); or adefovir dipivoxil 10 mg per day (oral dose); or grace entecavir 0.5-1mg per day (oral dose); or behalftelbivudine 600 mg per day (oral dose).
Supportive therapy are allowed to use on patients not including intravenous infusions of plasma or albumin.
Intervention Type
Procedure
Intervention Name(s)
stem cell transplantation through interventional procedure
Other Intervention Name(s)
UCMSC transplantation
Intervention Description
interventional procedure once
Intervention Type
Drug
Intervention Name(s)
antiviral therapy (lamivudine, other antiviral drugs)
Other Intervention Name(s)
lamivudine or other antiviral drugs.
Intervention Description
lamivudine, 100 mg per day (oral dose); or adefovir dipivoxil 10 mg per day (oral dose); or grace entecavir 0.5-1mg per day (oral dose); or behalftelbivudine 600 mg per day (oral dose).
Primary Outcome Measure Information:
Title
liver volume calculated by MRI
Description
Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.
Time Frame
baseline
Title
change from baseline in liver volume calculated by MRI at 6 months
Description
Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.
Time Frame
6 months after treatment
Title
change from baseline in liver volume calculated by MRI at 12 months
Description
Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.
Time Frame
12 months after treatment
Secondary Outcome Measure Information:
Title
blood biochemistry
Description
alanine aminotransferase
aspartate aminotransferase
gamma-glutamyltransferase(GGT)
alkaline phosphatase
total bilirubin
direct bilirubin
The total bile acid (TBA)
albumin
the proportion of white balls
Time Frame
baseline, 1,3,6 and 12 months after treatment or transplantation
Title
blood test
Description
platelet count (PLT)
mean platelet volume (MPV)
platelet distribution width (PDW)
platelet hematocrit (PCT)
alpha feto protein (AFP)
Time Frame
baseline,1,3,6 and 12 months after treatment or transplantation
Title
liver enzyme fiber spectrum
Description
laminin (LN)
Ⅳ collagen detection (CIV)
hyaluronic acid (HA)
procollagen Ⅲ(PC Ⅲ)
Time Frame
baseline,1,3,6 and 12 months after treatment or transplantation
Title
coagulation
Description
prothrombin time (PT)
activated partial thromboplastin time (APTT)
fibrinogen (FIB)
thrombin time (TT)
Time Frame
baselin,1,3,6 and 12 months after treatment or transplantation
Title
portal vein and splenic vein measure
Description
1)Portal vein diameter (Dpv) 2)Portal vein maximum velocity (Vmaxpv) 3)Portal vein blood flow per minute (Qpv) 4) The splenic vein diameter (Dsv) 5) Splenic vein maximum flow velocity (Vmaxsv) 6) Splenic vein blood flow per minute (Qsv)
Time Frame
baseline,1,3,6 and 12 months after treatment or transplantation
Title
estrogen and progestin in blood
Description
estrogen and progestin
Time Frame
baseline,1,3,6 and 12 months after treatment or transplantation
Other Pre-specified Outcome Measures:
Title
liver biopsy
Description
The result of liver biopsy judged by the same one expert.
Time Frame
baseline,6 and 12 months after transplantation
Title
gastroscopy
Description
Observe and photograph the related varicose veins.
Time Frame
baseline,6 and 12 months after treatment or transplantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of liver cirrhosis;
Without hepatic encephalopathy;
No ascites or have easily dissipated ascites;
Value of bilirubin is less than 100;
Value of albumin is greater than 16 g / L;
Prothrombin time is less than 21 seconds;
Exclusion Criteria:
Severe cardiovascular disease, and immunocompromised patients;
Patients with localized lesions affecting graft infection;
Coagulation disorders;
Liver nodules more than 2cm or Liver cancer.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yihua An, PhD
Phone
0086-10-57976845
Email
doctoran2010@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yihua An, PhD
Organizational Affiliation
Department of Stem Cell Transplantation, the General Hospital of Chinese People's Armed Police Force
Official's Role
Study Director
Facility Information:
Facility Name
Yihua An
City
Beijing
Country
China
12. IPD Sharing Statement
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Difference in Efficacy Between Stem Cell Transplantation and Classical Therapy in Liver Cirrhosis Patients
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