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

March 30, 2026 updated by: Xingshun Qi, General Hospital of Shenyang Military Region

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110840
        • General Hospital of Northern Theater Command

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single-infusion group
Single peripheral venous infusion of stem cells
Biological: umbilical cord-mesenchymal stem cells
Umbilical cord mesenchymal stem cells injected through peripheral veins
Other Names:
  • UC-MSCs
Experimental: Double-infusion group
Repeated peripheral venous infusion of stem cells within one month
Biological: umbilical cord-mesenchymal stem cells
Umbilical cord mesenchymal stem cells injected through peripheral veins
Other Names:
  • UC-MSCs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with Child A
Time Frame: 24 weeks
Patients with Child A
24 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Hospital of Shenyang Military Region

Investigators

  • Study Director: Xingshun Qi, MD, The General Hospital of Northern Theater Command
  • Principal Investigator: Wen Ning, MM, The General Hospital of Northern Theater Command

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2024

Primary Completion (Actual)

December 30, 2025

Study Completion (Actual)

December 30, 2025

Study Registration Dates

First Submitted

January 29, 2024

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Actual)

February 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XHNKKY-DFSC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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