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

Phase 1

• Conditions: Liver Cirrhosis
• Interventions: Procedure: stem cell transplantation through interventional procedure; Drug: antiviral therapy (lamivudine, other antiviral drugs)

• Registration Number: NCT01718587
• Lead Sponsor: General Hospital of Chinese Armed Police Forces

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.

Study Timeline

• Status Verified: 2012-10
• Study First Submitted: 2012-10-25
• Study First Submitted QC: 2012-10-30
• Last Update Submitted: 2012-10-30
• Study First Posted: 2012-10-31
• Last Update Posted: 2012-10-31
• Study Start: 2012-11
• Primary Completion: 2013-05
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
stem cell transplantation therapy	stem cell transplantation through interventional procedure	umbilical cord mesenchyma stem cell transplantation through interventional procedures do in liver cirrhosis patients.
antiviral therapy	antiviral therapy (lamivudine, other antiviral drugs)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
blood biochemistry	baseline, 1,3,6 and 12 months after treatment or transplantation	1. alanine aminotransferase; 2. aspartate aminotransferase; 3. gamma-glutamyltransferase(GGT); 4. alkaline phosphatase; 5. total bilirubin; 6. direct bilirubin; 7. The total bile acid (TBA); 8. albumin; 9. the proportion of white balls
blood test	baseline,1,3,6 and 12 months after treatment or transplantation	1. platelet count (PLT); 2. mean platelet volume (MPV); 3. platelet distribution width (PDW); 4. platelet hematocrit (PCT); 5. alpha feto protein (AFP)
liver enzyme fiber spectrum	baseline,1,3,6 and 12 months after treatment or transplantation	1. laminin (LN); 2. Ⅳ collagen detection (CIV); 3. hyaluronic acid (HA); 4. procollagen Ⅲ(PC Ⅲ)
coagulation	baselin,1,3,6 and 12 months after treatment or transplantation	1. prothrombin time (PT); 2. activated partial thromboplastin time (APTT); 3. fibrinogen (FIB); 4. thrombin time (TT)
portal vein and splenic vein measure	baseline,1,3,6 and 12 months after treatment or transplantation	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	baseline,1,3,6 and 12 months after treatment or transplantation	estrogen and progestin

Trial Locations

Locations (1)

Yihua An; 🇨🇳 Beijing, China