Human Umbilical Cord-Mesenchymal Stem Cells for Hepatic Cirrhosis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for Hepatic Cirrhosis.

Detailed Description
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Human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into mature cells typical of several tissues, which have been confirmed in in vivo and in vitro experiments. There have been few clinical reports describing umbilical cord mesenchymal stem cells for treatment of Hepatic Cirrhosis. To investigate the effects of hUC-MSC treatment for Hepatic Cirrhosis, 20 patients with Hepatic Cirrhosis will be enrolled and receive 4 times of hUC-MSC transplantation.

Official Title
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Safety and Efficacy Study of Human Umbilical Cord-Mesenchymal Stem Cells for Hepatic Cirrhosis

Conditions
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Hepatic Cirrhosis

Intervention / Treatment
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* Biological: Human umbilical cord mesenchymal stem cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient who have signed the informed consent document; Clinical, radiological, or biochemical evidence of liver cirrhosis. Exclusion Criteria: Pregnant women or lactating mothers; Patients who have received any anti-inflammatory drugs including herb-drug within 14 days; Patients who received any drug by intra-articular injection for treatment within 2 months prior to this enrollment; Patients with positive human immunodeficiency (HIV) at screening indicative of current of pass infection; Abnormal blood coagulation, combine other tumor or special condition; Patients who had participated in other clinical trials within three months prior to this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: hUC-MSC treatment<br>Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up. | Biological: Human umbilical cord mesenchymal stem cells<br>* A single dose of 2×107 hUC-MSC will be implanted to patients by intravenous infusion or Hepatic artery intervention, and repeated every week for four times.<br>* Other names: hUC-MSC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of adverse events | According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatic function | Include AST, ALT, T-Bil and A/G. | 1, 3 ,6 and 12 months | 
| Liver fibrosis index | The level of Hyaluronidase,Laminin,Procollagen Ⅲ and Collagen Type IV in serum. | 1, 3 ,6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stem cell, Human Umbilical Cord Mesenchymal Stem Cell, Mesenchymal Stem Cell, Hepatic Cirrhosis