Clinical trial

Efficacy and Safety of Different Frequencies of Human Umbilical Cord-mesenchymal Stem Cells Through Peripheral Vein in Patients With End-stage Liver Disease

Name
XHNKKY-DFSC
Description
Stem cells are non-terminal cells that can self renew and replicate through symmetric or asymmetric division, with the potential to differentiate into different types of cells and tissues. Multiple studies have shown that mesenchymal stem cell has good safety and effectiveness in improving acute or chronic liver injury. Randomized controlled trials have confirmed the efficacy of single infusion of stem cells in treating ESLD. It seems that the multiple infusion is better than single infusion.
Trial arms
Trial start
2024-02-01
Estimated PCD
2025-01-01
Trial end
2025-03-01
Status
Not yet recruiting
Treatment
umbilical cord-mesenchymal stem cells
Umbilical cord mesenchymal stem cells injected through peripheral veins
Arms:
Double-infusion group, Single-infusion group
Other names:
UC-MSCs
Size
92
Primary endpoint
Proportion of patients with Child A
24 weeks
Eligibility criteria
Inclusion Criteria: * 1. 18-80 years old * 2. End-stage liver disease * 3. Signed 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 92, 'type': 'ESTIMATED'}}
Updated at
2024-02-06

1 organization

1 product

1 indication