Effect of Different Dosage 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: Active, not recruiting

Conditions: End-stage Liver Diseases

Treatments: Biological: umbilical cord-mesenchymal stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT06167473

XHNKKY-DDSC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 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. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups

low-dose stem cell group (1×10^6cells/kg per infusion)

Experimental group

Description:

Peripheral intravenous infusion of low-dose stem cells

Treatment:

Biological: umbilical cord-mesenchymal stem cells

medium-high-dose stem cell group (3×10^6cells/kg per infusion)

Experimental group

Description:

Peripheral intravenous infusion of medium-high-dose stem cells

Treatment:

Biological: umbilical cord-mesenchymal stem cells