Difference in Efficacy Between Stem Cell Transplantation and Classical Therapy in Liver Cirrhosis Patients

Difference in Efficacy Between Umbilical Cord Mesenchyma Stem Cell Transplantation and Classical Therapy in Liver Cirrhosis Patients

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.

Study Overview

• Status: Unknown
• Conditions: Liver Cirrhosis
• Intervention / Treatment: Procedure: stem cell transplantation through interventional procedure; Drug: antiviral therapy (lamivudine, other antiviral drugs)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Yihua An

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: stem cell transplantation therapy; umbilical cord mesenchyma stem cell transplantation through interventional procedures do in liver cirrhosis patients.	Procedure: stem cell transplantation through interventional procedure; interventional procedure once; Other Names: UCMSC transplantation
Active Comparator: antiviral therapy; 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.	Drug: antiviral therapy (lamivudine, other antiviral drugs); 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).; Other Names: lamivudine or other antiviral drugs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
liver volume calculated by MRI	Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.	baseline
change from baseline in liver volume calculated by MRI at 6 months	Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.	6 months after treatment
change from baseline in liver volume calculated by MRI at 12 months	Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.	12 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	baseline, 1,3,6 and 12 months after treatment or transplantation
blood test	platelet count (PLT); mean platelet volume (MPV); platelet distribution width (PDW); platelet hematocrit (PCT); alpha feto protein (AFP)	baseline,1,3,6 and 12 months after treatment or transplantation
liver enzyme fiber spectrum	laminin (LN); Ⅳ collagen detection (CIV); hyaluronic acid (HA); procollagen Ⅲ(PC Ⅲ)	baseline,1,3,6 and 12 months after treatment or transplantation
coagulation	prothrombin time (PT); activated partial thromboplastin time (APTT); fibrinogen (FIB); thrombin time (TT)	baselin,1,3,6 and 12 months after treatment or transplantation
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)	baseline,1,3,6 and 12 months after treatment or transplantation
estrogen and progestin in blood	estrogen and progestin	baseline,1,3,6 and 12 months after treatment or transplantation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
liver biopsy	The result of liver biopsy judged by the same one expert.	baseline,6 and 12 months after transplantation
gastroscopy	Observe and photograph the related varicose veins.	baseline,6 and 12 months after treatment or transplantation

Collaborators and Investigators

• Sponsor: General Hospital of Chinese Armed Police Forces
• Collaborators: The First Hospital of Hebei Medical University
• Investigators: Study Director: Yihua An, PhD, Department of Stem Cell Transplantation, the General Hospital of Chinese People's Armed Police Force

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Anticipated): May 1, 2013
• Study Completion (Anticipated): July 1, 2014

Study Registration Dates

• First Submitted: October 25, 2012
• First Submitted That Met QC Criteria: October 30, 2012
• First Posted (Estimate): October 31, 2012

Study Record Updates

• Last Update Posted (Estimate): October 31, 2012
• Last Update Submitted That Met QC Criteria: October 30, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: antiviral therapy; liver cirrhosis; umbilical cord mesenchyma stem cell
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Lamivudine; Antiviral Agents
• Other Study ID Numbers: 2012-10-09 TC liver cirrhosis