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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Liver Cirrhosis

Intervention / Treatment
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* Procedure: stem cell transplantation through interventional procedure
* Drug: antiviral therapy (lamivudine, other antiviral drugs)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stem cell transplantation therapy<br>umbilical cord mesenchyma stem cell transplantation through interventional procedures do in liver cirrhosis patients. | Procedure: stem cell transplantation through interventional procedure<br>* interventional procedure once<br>* Other names: UCMSC transplantation;|
| Active Comparator: antiviral therapy<br>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)<br>* 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).<br>* Other names: lamivudine or other antiviral drugs.;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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umbilical cord mesenchyma stem cell, liver cirrhosis, antiviral therapy