Effect of Different Dosage of Umbilical Cord-mesenchymal Stem Cells Through Peripheral Vein in Patients with ESLD
- Conditions
- End-stage Liver Diseases
- Interventions
- Biological: umbilical cord-mesenchymal stem cells
- Registration Number
- NCT06167473
- Lead Sponsor
- General Hospital of Shenyang Military Region
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 22
- 18-80 years old
- End-stage liver disease
- Sign informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description low-dose stem cell group (1×10^6cells/kg per infusion) umbilical cord-mesenchymal stem cells Peripheral intravenous infusion of low-dose stem cells medium-high-dose stem cell group (3×10^6cells/kg per infusion) umbilical cord-mesenchymal stem cells Peripheral intravenous infusion of medium-high-dose stem cells
- Primary Outcome Measures
Name Time Method Survival rate 1 year Number of subjects surviving after one year
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
General Hospital of Northern Theater Command
🇨🇳Shenyang, Liaoning, China