NCT06242405

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
29 days until next milestone

Study Start

First participant enrolled

March 5, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

March 31, 2026

Status Verified

February 1, 2025

Enrollment Period

1.8 years

First QC Date

January 29, 2024

Last Update Submit

March 30, 2026

Conditions

End-Stage Liver DIsease

Keywords

cirrhosisend-stage liver diseasesumbilical cord-mesenchymal stem cellsrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with Child A

    Patients with Child A

    24 weeks

Secondary Outcomes (3)

  • Change in liver function parameters

    24 weeks

  • Incidence of hepatic decompensation events

    24 weeks

  • Survival rate and liver transplant rate

    24 weeks

Study Arms (2)

Single-infusion group

EXPERIMENTAL

Single peripheral venous infusion of stem cells

Biological: umbilical cord-mesenchymal stem cells

Double-infusion group

EXPERIMENTAL

Repeated peripheral venous infusion of stem cells within one month

Biological: umbilical cord-mesenchymal stem cells

Interventions

umbilical cord-mesenchymal stem cellsBIOLOGICAL

Umbilical cord mesenchymal stem cells injected through peripheral veins

Also known as: UC-MSCs
Double-infusion groupSingle-infusion group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 18-80 years old
  • \. End-stage liver disease
  • \. Signed 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Northern Theater Command

Shenyang, Liaoning, 110840, China

Location

Related Publications (2)

  • Volarevic V, Nurkovic J, Arsenijevic N, Stojkovic M. Concise review: Therapeutic potential of mesenchymal stem cells for the treatment of acute liver failure and cirrhosis. Stem Cells. 2014 Nov;32(11):2818-23. doi: 10.1002/stem.1818.

    PMID: 25154380RESULT

  • Wang J, Li Q, Li W, Mendez-Sanchez N, Liu X, Qi X. Stem Cell Therapy for Liver Diseases: Current Perspectives. Front Biosci (Landmark Ed). 2023 Dec 28;28(12):359. doi: 10.31083/j.fbl2812359.

    PMID: 38179765RESULT

MeSH Terms

Conditions

End Stage Liver DiseaseFibrosis

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Xingshun Qi, MD

    The General Hospital of Northern Theater Command

    STUDY DIRECTOR

  • Wen Ning, 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

Study Record Dates

First Submitted

January 29, 2024

First Posted

February 5, 2024

Study Start

March 5, 2024

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

March 31, 2026

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)