End-stage Liver Diseases
Conditions
Keywords
cirrhosis, end-stage liver diseases, umbilical cord-mesenchymal stem cells, randomized controlled trial
Brief summary
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
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.
Interventions
BIOLOGICALumbilical cord-mesenchymal stem cells
Different dosage of umbilical cord-mesenchymal stem cells through peripheral vein
Sponsors
General Hospital of Shenyang Military Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 18-80 years old 2. End-stage liver disease 3. Sign informed consent
Exclusion criteria
1. Tumours of the liver or other organs 2. Liver transplantation recipients 3. 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 4. Other diseases that may seriously affect the survival 5. Human immunodeficiency syndrome 6. Interferon or glucocorticoid therapy within 1 year 7. Treated for mental illness 8. Participation in other clinical trials within 30 days 9. Pregnant or breastfeeding subjects 10. Allergic asthma, allergic urticaria, eczema, or a history of multiple drug and food allergies 11. Other circumstances that are unsuitable for participation in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival rate | 1 year | Number of subjects surviving after one year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in liver function | 1, 4, 8, 12, 24, and 48 weeks | 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 |
| Incidence of hepatic decompensation events | 1 year | Number of patients who developed gastrointestinal bleeding, ascites and hepatic encephalopathy |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORMengfan Ruan, MM
The General Hospital of Northern Theater Command
Outcome results
None listed