Human Umbilical Cord-mesenchymal Stem Cells Via Different Transplantation Routes in ESLD

NCT ID: NCT06984497

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2027-12-31

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 human umbilical cord mesenchymal stem cell has good safety and effectiveness in improving acute or chronic liver injury.

Stem cell therapy for end-stage liver disease (ESLD) can be administered through various routes, among which hepatic artery and peripheral vein infusions are the most commonly used in clinical practice. The efficacy of hepatic artery infusion appears to be greater than that of peripheral vein infusion.

Detailed Description

Thirty-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 6 months. They will be randomly assigned to peripheral vein infusion and hepatic arterial infusion of human umbilical cord mesenchymal stem cell groups. 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 at weeks 4, 12, and 24 post-infusion.

Conditions

End-Stage Liver Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Peripheral veins infusion group

Peripheral veins infusion of stem cells

Group Type: EXPERIMENTAL

Infusion of umbilical cord-mesenchymal stem cells through peripheral veins

Intervention Type: OTHER

Umbilical cord-mesenchymal stem cells injected through peripheral veins

Hepatic arterial infusion group

Hepatic arterial infusion of stem cells

Group Type: EXPERIMENTAL

Infusion of umbilical cord-mesenchymal stem cells through hepatic artery

Intervention Type: OTHER

Umbilical cord-mesenchymal stem cells injected through hepatic artery

Interventions

Infusion of umbilical cord-mesenchymal stem cells through peripheral veins

Umbilical cord-mesenchymal stem cells injected through peripheral veins

Intervention Type: OTHER

Infusion of umbilical cord-mesenchymal stem cells through hepatic artery

Umbilical cord-mesenchymal stem cells injected through hepatic artery

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. 18-80 years old

-

2. End-stage liver disease

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3. Signed informed consent

Exclusion Criteria

1. Tumours of the liver or other organs

-

2. Liver transplantation recipients

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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

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4. Other diseases that may seriously affect the survival

-

5. Human immunodeficiency syndrome

-

6. Interferon or glucocorticoid therapy within 1 year

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7. Treated for mental illness

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8. Participation in other clinical trials within 30 days

-

9. Pregnant or breastfeeding subjects

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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

General Hospital of Shenyang Military Region

OTHER

Sponsor Role: lead

Responsible Party

Xingshun Qi

Director of Department of Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xingshun Qi, MD

Role: STUDY_DIRECTOR

The General Hospital of Northern Theater Command Study Director

Beilei Zhang, MM

Role: PRINCIPAL_INVESTIGATOR

The General Hospital of Northern Theater Command Study Director

Locations

General Hospital of Northern Theater Command Recruiting

Shenyang, Liaoning, China

Countries

China

Central Contacts

Xingshun Qi, MD

Role: CONTACT

xingshunqi@126.com

18909881019

Beilei Zhang, MM

Role: CONTACT

15191080726@163.com

15191080726

Facility Contacts

Xingshun Qi, MD

Role: primary

xingshunqi@126.com

18909881019

Beilei Zhang, MM

Role: backup

15191080726@163.com

15191080726

References

Lyra AC, Soares MB, da Silva LF, Braga EL, Oliveira SA, Fortes MF, Silva AG, Brustolim D, Genser B, Dos Santos RR, Lyra LG. Infusion of autologous bone marrow mononuclear cells through hepatic artery results in a short-term improvement of liver function in patients with chronic liver disease: a pilot randomized controlled study. Eur J Gastroenterol Hepatol. 2010 Jan;22(1):33-42. doi: 10.1097/MEG.0b013e32832eb69a.

Reference Type: BACKGROUND

PMID: 19654548 (View on PubMed)

Zhou GP, Jiang YZ, Sun LY, Zhu ZJ. Therapeutic effect and safety of stem cell therapy for chronic liver disease: a systematic review and meta-analysis of randomized controlled trials. Stem Cell Res Ther. 2020 Sep 25;11(1):419. doi: 10.1186/s13287-020-01935-w.

Reference Type: BACKGROUND

PMID: 32977828 (View on PubMed)

Other Identifiers

XHNKKY-DRSC

Identifier Type: -

Identifier Source: org_study_id