Human Umbilical Cord Mesenchymal Stem Cells Transplantation for Patients With Decompensated Liver Cirrhosis

Study Overview
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Brief Summary
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Although liver transplantation provide a option to cure patients suffering with decompensated liver cirrhosis this condition, lack of donors, postoperative complications, especially rejection, and high cost limit its application. Bone marrow derived mesenchymal stem cells (BM-MSCs) have been shown to replace hepatocytes in injured liver, effectively rescued experimental liver failure and contributed to liver regeneration, which suggest the novel and promising therapeutic strategy In this study, the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSCs) transplantation for patients with decompensated liver cirrhosis will be evaluated.

Detailed Description
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To investigate the safety and efficacy of human umbilical cord mesenchymal stem cells transplantation in patients of decompensated liver cirrhosis.

Official Title
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Phase Ι/Π Study of Human Umbilical Cord Mesenchymal Stem Cells Transplantation for Patients With Decompensated Liver Cirrhosis

Conditions
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Liver Cirrhosis

Intervention / Treatment
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* Biological: conventional therapy plus low dose hUC-MSCs treatment
* Biological: conventional therapy plus medium dose hUC-MSCs treatment
* Biological: conventional therapy plus high dose hUC-MSCs treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent. Aged 18-70 years. Decompensated liver cirrhosis, Child-Pugh B/C (7-12 points); or Meld score≦21. Expecting lifetime is over 2 months. Hepatitis B decompensated liver cirrhosis patients need antiviral therapy. Exclusion Criteria: Severe drug allergic history or anaphylaxis. Severe problems in other vital organs(e.g. the heart, renal or lungs) Severe problems in psychiatric disease,such as Schizophrenia,et al Severe bacteria infection. Malignancies. Alcoholism or drug abuse. Plan to have liver transplantation in 3 months. Pregnancy Candidates who are participating in other study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Conventional plus hUC-MSCs treatment (low dose)<br> | Biological: conventional therapy plus low dose hUC-MSCs treatment<br>* patients will receive the conventional therapy plus low dose hUC-MSCs treatment<br>|
| Experimental: conventional therapy plus hUC-MSCs treatment （medium dose）<br> | Biological: conventional therapy plus medium dose hUC-MSCs treatment<br>* patients will receive conventional therapy plus medium dose hUC-MSCs treatment<br>|
| Experimental: conventional therapy plus hUC-MSCs treatment （high dose）<br> | Biological: conventional therapy plus high dose hUC-MSCs treatment<br>* patients will receive conventional therapy plus high dose hUC-MSCs treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) |  | 1 year after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver function improvement |  | 1 year after treatment | 
| The size of liver and the width of portal venous |  | 1 year after treatment | 
| Incidence of hepatocellular carcinoma within 1 year |  | 1 year after treatment | 
| Child-Pugh score, MELD score,SF36-quality of life (SF36-QOL) |  | 1 year after treatment | 
| The clinical symptom improvement(including appetite, debilitation, abdominal distension, edema of lower limbs, et al ) |  | 1 year after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Decompensated Liver Cirrhosis, Umbilical Cord Mesenchymal Stem Cells