Risk Factors Affecting MSC Efficacy in ACLF Patients

Sun Yat-sen University

Status: Enrolling

Conditions: Acute-On-Chronic Liver Failure

Treatments: Other: Not applicable- observational study

Study type: Observational

Funder types: Other

Identifiers

NCT07198854

RISFAC-MSCs

Details and patient eligibility

About

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.

Enrollment: 446 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.