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

NCT ID: NCT06242405

Last Updated: 2025-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-05

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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End-Stage Liver DIsease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Single-infusion group

Single peripheral venous infusion of stem cells

Group Type EXPERIMENTAL

umbilical cord-mesenchymal stem cells

Intervention Type BIOLOGICAL

Umbilical cord mesenchymal stem cells injected through peripheral veins

Double-infusion group

Repeated peripheral venous infusion of stem cells within one month

Group Type EXPERIMENTAL

umbilical cord-mesenchymal stem cells

Intervention Type BIOLOGICAL

Umbilical cord mesenchymal stem cells injected through peripheral veins

Interventions

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umbilical cord-mesenchymal stem cells

Umbilical cord mesenchymal stem cells injected through peripheral veins

Intervention Type BIOLOGICAL

Other Intervention Names

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UC-MSCs

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General Hospital of Shenyang Military Region

OTHER

Sponsor Role lead

Responsible Party

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Xingshun Qi

Director of Department of Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xingshun Qi, MD

Role: STUDY_DIRECTOR

The General Hospital of Northern Theater Command

Wen Ning, MM

Role: PRINCIPAL_INVESTIGATOR

The General Hospital of Northern Theater Command

Locations

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General Hospital of Northern Theater Command

Shenyang, Liaoning, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xingshun Qi, MD

Role: CONTACT

18909881019

Wen Ning, MM

Role: CONTACT

13390132472

Facility Contacts

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Xingshun Qi, MD

Role: primary

18909881019

Wen Ning, MM

Role: backup

13390132472

References

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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.

Reference Type BACKGROUND
PMID: 25154380 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38179765 (View on PubMed)

Other Identifiers

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XHNKKY-DFSC

Identifier Type: -

Identifier Source: org_study_id

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