Effect of Different Dosage of Umbilical Cord-mesenchymal Stem Cells Through Peripheral Vein in Patients With ESLD

Study Overview
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Brief Summary
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There is a rise in the prevalence of end-stage liver disease during the last decade. End-stage liver disease has become one of the leading causes of death in Western countries. Liver transplantation is the only curative treatment for patients with end-stage liver disease. However, the shortage of donor, high cost, and postoperative complications limit its wide application in clinical practice. At present, stem cell-based therapy has been developed as an alternative treatment for end-stage liver disease. Stem cells can be differentiated into a variety of cell types, and stem cell transplantation, mainly umbilical cord-mesenchymal stem cells, has attracted more and more attention in the treatment of end-stage liver disease. The investigators therefore conduct a randomised controlled trial to investigate the efficacy and safety of human umbilical cord tissue mesenchymal stem cells for the treatment of end-stage liver disease.

Detailed Description
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Twenty-two subjects with end-stage liver disease attending the Department of Gastroenterology of the General Hospital of the Northern Theatre of Operations are expected to be enrolled over a period of 1 year. The participants will be randomly divided into a low-dose stem cell group (1×10^6cells/kg per infusion) and a medium-high-dose stem cell group (3×10^6cells/kg per infusion), which are infused by peripheral vein. The investigators will observe ALT, AST, ALP, TBIL, ALB, PT, INR, MELD score, and Child-Pugh score in patients at weeks 1, 4, 8, 12, 24, and 48 post-infusion.

Official Title
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Efficacy and Safety of Different Dosage of Umbilical Cord-mesenchymal Stem Cells Through Peripheral Vein in Patients With End-stage Liver Diseases

Conditions
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End-stage Liver Diseases

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-80 years old End-stage liver disease Sign informed consent Exclusion Criteria: Tumours of the liver or other organs Liver transplantation recipients Acute myocardial infarction, acute heart failure, type I and type II respiratory failure, pulmonary embolism, acute cerebral infarction, acute cerebral haemorrhage and other serious cardiopulmonary diseases Other diseases that may seriously affect the survival Human immunodeficiency syndrome Interferon or glucocorticoid therapy within 1 year Treated for mental illness Participation in other clinical trials within 30 days Pregnant or breastfeeding subjects Allergic asthma, allergic urticaria, eczema, or a history of multiple drug and food allergies Other circumstances that are unsuitable for participation in 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Before enrollment, all patients and/or their relatives will be informed about the study protocol, and sign the written informed consent forms. Eligible patients are randomly assigned at a ratio of 1:1 to low-dose stem cell group (1×10^6cells/kg per infusion) and a medium-high-dose stem cell group (3×10^6cells/kg per infusion).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low-dose stem cell group (1×10^6cells/kg per infusion)<br>Peripheral intravenous infusion of low-dose stem cells | Biological: umbilical cord-mesenchymal stem cells<br>* Different dosage of umbilical cord-mesenchymal stem cells through peripheral vein<br>* Other names: UC-MSCs;|
| Experimental: medium-high-dose stem cell group (3×10^6cells/kg per infusion)<br>Peripheral intravenous infusion of medium-high-dose stem cells | Biological: umbilical cord-mesenchymal stem cells<br>* Different dosage of umbilical cord-mesenchymal stem cells through peripheral vein<br>* Other names: UC-MSCs;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate | Number of subjects surviving after one year | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in liver function | The values of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, serum albumin, prothrombin time, and international normalized ratio and the scores of MELD and Child-Pugh | 1, 4, 8, 12, 24, and 48 weeks | 
| Incidence of hepatic decompensation events | Number of patients who developed gastrointestinal bleeding, ascites and hepatic encephalopathy | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cirrhosis, end-stage liver diseases, umbilical cord-mesenchymal stem cells, randomized controlled trial