Safety and Efficacy of Stem Cell Transplantation for Treatment of Liver Cirrhosis

Study Overview
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Brief Summary
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Mainstream of current treatment of liver cirrhosis is liver transplantation, but there are high cost, risk and immune rejection and other issues. 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 in patients liver cirrhosis will be evaluated.

Detailed Description
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This study included three research centers, each center were carried out 25 cases of liver cirrhosis in patients with stem cell transplantation. All the selection and exclusion criteria are same, data summary and analysis will be complete by the epidemiological commissioner.

Official Title
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Safety and Efficacy of Umbilical Cord Mesenchyma Stem Cell Transplantation in Liver Cirrhosis Patients

Conditions
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Other Surgical Procedures

Intervention / Treatment
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* Procedure: stem cell transplantation through interventional procedures


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
Intervention Model: Single Group 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 procedures<br>* one time interventional procedures<br>* Other names: umbilical cord mesenchyma stem cell transplantation;|

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. | 3 days before transplantation, 6 and 12 months after transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| liver biopsy | The result of liver biopsy judged by the expert. | whinin 7 days before transplantation, 6 and 12 months after transplantation | 
| gastroscopy | Observe and photograph the related varicose veins. | whinin 7 days before transplantation, 6 and 12 months after transplantation | 
| blood biochemistry | alanine aminotransferase aspartate aminotransferase gamma-glutamyltransferase(GGT) alkaline phosphatase total bilirubin direct bilirubin The total bile acid (TBA) serum cholinesterase (CHE) total cholesterol (TC) albumin the proportion of white balls | whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation | 
| blood test | platelet count (PLT) mean platelet volume (MPV) platelet distribution width (PDW) platelet hematocrit (PCT) alpha feto protein(AFP) | whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation | 
| liver enzyme fiber spectrum | laminin (LN) Ⅳ collagen detection (CIV) hyaluronic acid (HA) procollagen Ⅲ(PC Ⅲ) | whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation | 
| coagulation | prothrombin time (PT) activated partial thromboplastin time (APTT) fibrinogen (FIB) thrombin time (TT) | whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation | 
| portal vein and splenic vein measure | Portal vein diameter (Dpv); Portal vein maximum velocity (Vmaxpv); Portal vein blood flow per minute (Qpv); The splenic vein diameter (Dsv); Splenic vein maximum flow velocity (Vmaxsv); Splenic vein blood flow per minute (Qsv). | whinin 7 days before transplantation, 1,3,6 and 12 months after 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