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NCT Number: NCT07198854

Risk Factors Affecting MSC Efficacy in ACLF Patients

Mesenchymal stromal cells (MSCs) are potential therapy for many diseases, with the ability of tissue regeneration, repair and immunomodulation. Acute-on-chronic liver failure (ACLF) is a severe disease with high mortality. Previous studies showed that MSCs can improve the outcomes of Hepatitis B virus (HBV)-related ACLF patients. However, there are still some ACLF patients who have not benefited from MSC treatment. Thus, searching for risk factors affecting MSC efficacy in ACLF patients is of great significance for promotion of MSCs therapy.

This retrospective study will perform at a single center in southern China. Consecutive HBV related-ACLF patients treated with MSCs at the Third Affiliated Hospital of Sun Yat-sen University from January 2010 to October 2018 will be included. The clinical data including survival status, liver functions, complications et al. will be collected and analyzed, with the purpose of identifying the risk factors of HBV-related ACLF patients received MSCs injection and improving the efficacy of MSCs therapy furtherly.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Location status: Recruiting

Location contact

Junfeng Chen, Dr.

CONTACT

[email protected]

86-20-85252363

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of acute-on-chronic liver failure; Positive serum HBV surface antigen for more than 6 months; Received MSCs infusion more than one time.

Exclusion criteria

  • Systemic or local malignancy; Hepatitis C virus infection; HIV infection or other immunodeficiency disease; Marked organ dysfunction (e.g., renal dysfunction); Pregnancy or lactation; Hyperthyroidism or other primary thyroid diseases; Incomplete data or lost to follow-up; Hospital stay < 1 day.

Treatment and study plan

Not applicable- observational study

Other

This is a retrospective cohort study and intervention is not applicable.

Primary outcomes

  1. Survival status

    Time frame: 90 days

    The survival status and survival time of the participants after receiving MSCs infusion will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Analysis of Risk Factors Affecting Mesenchymal Stem Cells Efficacy in Hepatitis B Related Acute-on-chronic Liver Failure

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Sep 30, 2025
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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