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

General Hospital of Northern Theater Command of Chinese People's Liberation Army

Status: Enrolling

Conditions: End-Stage Liver DIsease

Treatments: Biological: umbilical cord-mesenchymal stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT06242405

XHNKKY-DFSC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

92 participants in 2 patient groups

Single-infusion group

Experimental group

Description:

Single peripheral venous infusion of stem cells

Treatment:

Biological: umbilical cord-mesenchymal stem cells

Double-infusion group

Experimental group

Description:

Repeated peripheral venous infusion of stem cells within one month

Treatment:

Biological: umbilical cord-mesenchymal stem cells