Factors that affect how well mesenchymal stromal cell (MSC) therapy works for hepatitis B–related acute-on-chronic liver failure.
Official title: Analysis of Risk Factors Affecting Mesenchymal Stem Cells Efficacy in Hepatitis B Related Acute-on-chronic Liver Failure
Run by Sun Yat-sen University · NCT07198854 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 446 (estimated) |
| Sponsor | Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | October 20, 2025 |
| Main results expected | December 30, 2025 |
| Study ends | June 30, 2026 |
| Registry record updated | November 28, 2025 |
| Trial ID | NCT07198854 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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AS1501 in ACLF: a two-stage dose study in adults with acute-on-chronic liver failure
This Phase II study tests AS1501 given by injection in adults with early ACLF to see if it’s safe and tolerable and to guide dosing.
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TAK-242 and G-CSF in ACLF: a new treatment approach for adults with acute-on-chronic liver failure
This trial tests whether adding TAK-242, with or without G-CSF, to standard ACLF care helps patients with severe alcoholic hepatitis and ACLF.
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Using different ROTEM cut-offs to guide blood transfusions before procedures in cirrhosis and ACLF
This will test whether using relaxed ROTEM cut-offs to decide on blood transfusions reduces the number of transfusions without raising bleeding risk for people with cirrhosis or ACLF and severe coagulopathy who need invasive procedures.
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Ceftazidime-avibactam vs high-dose meropenem for ACLF patients with hospital-acquired infections
This trial tests whether ceftazidime-avibactam can better treat infections in ACLF patients than high-dose meropenem given in extended infusions, aiming to spare carbapenems if possible.
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Evaluating a new treatment for liver failure and sepsis
This study is testing a new treatment for people with liver failure and sepsis to see if it can help them survive and improve their organ function.
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Using CytoSorb device for patients with acute on chronic liver failure
This study tests if using the CytoSorb device can help lower bilirubin and ammonia levels and improve muscle strength in patients with severe liver failure.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.