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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06242405

Enrollment

Registered

2024-02-05

Start date

2024-03-05

Completion date

2025-12-30

Last updated

2026-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-Stage Liver DIsease

Keywords

cirrhosis, end-stage liver diseases, umbilical cord-mesenchymal stem cells, randomized controlled trial

Brief summary

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.

Detailed description

Ninety-two participants with end-stage liver disease admitted to the Department of Gastroenterology of the General Hospital of Northern Theater Command are expected to be enrolled over a period of 1 year. The participants will be randomly divided into single-infusion and double-infusion stem cell groups by peripheral vein. The investigators will observe alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, albumin, prothrombin time, international normalized ratio, model for end-stage liver disease score, and Child-Pugh score in patients at weeks 24 post-infusion.

Interventions

BIOLOGICALumbilical cord-mesenchymal stem cells

Umbilical cord mesenchymal stem cells injected through peripheral veins

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Proportion of patients with Child A	24 weeks	Patients with Child A

Secondary

Measure	Time frame	Description
Change in liver function parameters	24 weeks	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	24 weeks	Number of patients who will develop gastrointestinal bleeding, ascites and hepatic encephalopathy
Survival rate and liver transplant rate	24 weeks	Number of patients surviving and undergoing liver transplantation

Countries

China

Contacts

STUDY_DIRECTORXingshun Qi, MD

The General Hospital of Northern Theater Command

PRINCIPAL_INVESTIGATORWen Ning, MM