Factors that affect how well mesenchymal stromal cell (MSC) therapy works for hepatitis B–related acute-on-chronic liver failure.
Analysis of Risk Factors Affecting Mesenchymal Stem Cells Efficacy in Hepatitis B Related Acute-on-chronic Liver Failure
Sun Yat-sen University · NCT07198854
This project will look back at people with hepatitis B–related ACLF who received MSC infusions to see which factors affect whether the treatment helps.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 446 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sun Yat-sen University (other) |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07198854 on ClinicalTrials.gov |
What this trial studies
This single-center retrospective analysis will include consecutive patients with hepatitis B–related ACLF treated with mesenchymal stromal cell (MSC) infusions at the Third Affiliated Hospital of Sun Yat-sen University between January 2010 and October 2018. Clinical data including survival status, liver function tests, and complications will be extracted from medical records. Patients with co-infections (HCV, HIV), active malignancy, marked organ dysfunction, pregnancy, primary thyroid disease, or incomplete records were excluded. Statistical analyses will identify clinical and demographic risk factors associated with whether patients derived benefit from MSC treatment.
Who should consider this trial
Good fit: Ideal candidates for the analysis are patients with hepatitis B–related ACLF who were HBsAg positive for more than six months and received more than one MSC infusion at the study hospital.
Not a fit: Patients with hepatitis C, HIV, active malignancy, marked other organ failure (e.g., renal dysfunction), pregnancy or primary thyroid disease, or those with incomplete records were excluded and are unlikely to be represented by the findings.
Why it matters
Potential benefit: If successful, clinicians could better identify which HBV-related ACLF patients are likely to benefit from MSC therapy and avoid giving ineffective treatment.
How similar studies have performed: Prior studies have reported that MSC therapy can improve outcomes in some HBV-related ACLF patients, but results have been mixed and not all patients benefit.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guangzhou, Guangdong
- Third Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (RECRUITING)
Study contacts
- Study coordinator: Dr. Chen
- Email: chenjf36@mail.sysu.edu.cn
- Phone: +86-20-85252081
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute-On-Chronic Liver Failure