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

NCT06167473 | Active Not Recruiting

• 1 other identifier: XHNKKY-DDSC
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

End-stage Liver Diseases

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Survival rate

  Number of subjects surviving after one year

  1 year

Secondary Outcomes (2)

• Changes in liver function

  1, 4, 8, 12, 24, and 48 weeks

• Incidence of hepatic decompensation events

  1 year

Study Arms (2)

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

EXPERIMENTAL

Peripheral intravenous infusion of low-dose stem cells

Biological: umbilical cord-mesenchymal stem cells

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

EXPERIMENTAL

Peripheral intravenous infusion of medium-high-dose stem cells

Biological: umbilical cord-mesenchymal stem cells

Interventions

umbilical cord-mesenchymal stem cells BIOLOGICAL

Different dosage of umbilical cord-mesenchymal stem cells through peripheral vein

Also known as: UC-MSCs

low-dose stem cell group (1×10^6cells/kg per infusion); medium-high-dose stem cell group (3×10^6cells/kg per infusion)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• End-stage liver disease
• Sign informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

General Hospital of Northern Theater Command

Shenyang, Liaoning, 110840, China

Location

Related Publications (3)

• Zhang L, Ma XJ, Fei YY, Han HT, Xu J, Cheng L, Li X. Stem cell therapy in liver regeneration: Focus on mesenchymal stem cells and induced pluripotent stem cells. Pharmacol Ther. 2022 Apr;232:108004. doi: 10.1016/j.pharmthera.2021.108004. Epub 2021 Sep 28.

  PMID: 34597754 BACKGROUND

• Khan S, Khan RS, Newsome PN. Cell Therapy for Liver Disease: From Promise to Reality. Semin Liver Dis. 2020 Nov;40(4):411-426. doi: 10.1055/s-0040-1717096. Epub 2020 Dec 24.

  PMID: 33764490 BACKGROUND

• Alfaifi M, Eom YW, Newsome PN, Baik SK. Mesenchymal stromal cell therapy for liver diseases. J Hepatol. 2018 Jun;68(6):1272-1285. doi: 10.1016/j.jhep.2018.01.030. Epub 2018 Feb 7.

  PMID: 29425678 BACKGROUND

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mengfan Ruan, MM

  The General Hospital of Northern Theater Command

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Gastroenterology

Model Details: Before enrollment, all patients and/or their relatives will be informed about the study protocol, and sign the written informed consent forms. Eligible patients are randomly assigned at a ratio of 1:1 to 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).

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 12, 2023
• Study Start: November 28, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)