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

NCT06984497 | Not Yet Recruiting

• 1 other identifier: XHNKKY-DRSC
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

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 24 weeks

  24 weeks

Secondary Outcomes (3)

• Changes in Model for End-Stage Liver Disease (MELD) score

  4, 12, and 24 weeks

• Changes in Child-Pugh score

  4, 12, and 24 weeks

• Incidence of hepatic decompensation events

  4, 12, and 24 weeks

Study Arms (2)

Peripheral veins infusion group

EXPERIMENTAL

Peripheral veins infusion of stem cells

Other: Infusion of umbilical cord-mesenchymal stem cells through peripheral veins

Hepatic arterial infusion group

EXPERIMENTAL

Hepatic arterial infusion of stem cells

Other: Infusion of umbilical cord-mesenchymal stem cells through hepatic artery

Interventions

Infusion of umbilical cord-mesenchymal stem cells through peripheral veins OTHER

Umbilical cord-mesenchymal stem cells injected through peripheral veins

Peripheral veins infusion group

Infusion of umbilical cord-mesenchymal stem cells through hepatic artery OTHER

Umbilical cord-mesenchymal stem cells injected through hepatic artery

Hepatic arterial infusion group

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
• 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

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

General Hospital of Northern Theater Command Recruiting

Shenyang, Liaoning, 110840, China

Location

Related Publications (2)

• 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.

  PMID: 19654548 BACKGROUND

• 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.

  PMID: 32977828 BACKGROUND

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xingshun Qi, MD

  The General Hospital of Northern Theater Command Study Director

  STUDY DIRECTOR

• Beilei Zhang, MM

  The General Hospital of Northern Theater Command Study Director

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xingshun Qi, MD

CONTACT

18909881019; xingshunqi@126.com

Beilei Zhang, MM

CONTACT

15191080726; 15191080726@163.com

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: May 12, 2025
• First Posted: May 22, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)