Acute on chronic liver failure (ACLF)
Conditions
Interventions
Intervention group:Human umbilical cord-derived mesenchymal stem cells(HUC-MSC)
Sponsors
The First Affiliated Hospital of PLA Air Force Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years(including 18 and 70 years), no gender limit; 2. Acute-on-chronic liver failure according to Live Failure Guideline(2018 Edition); 3. Patients with early and medium-term liver failure were enrolled according to the guidelines for the diagnosis and treatment of liver failure (2018 Edition); 4. All subjects and their partners have no birth plans within 6 months from screening to the end of the trial and agree to take effective non-drug contraceptive measures during the trial period; 5. The patient or adult family members agree to participate in this study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Active gastrointestinal bleeding, manifested as hematemesis and/or black stool; 2. Severe infections, including sepsis, septic shock, severe pneumonia (the diagnostic criteria for severe pneumonia refer to the 2007 American Academy of Infectious Diseases/American Thoracic Society diagnostic criteria for adult severe pneumonia), etc.; 3. Patients with CTCAE grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmia, and/or NYHA standard grade III-IV cardiac insufficiency or other acute serious complications; 4. Patients with solid and/or hematological tumors; 5. Those who have a history of alcohol or drug abuse within 6 months, or ACLF due to alcoholic liver abstinence for less than 6 months; 6. Participated in drug trials in the past 3 months; 7. The researcher believes that the patient has potential or has a disease or mental illness that interferes with the evaluation of this research; 8. Those who are allergic to cattle-derived products; 9. History of immunodeficiency, including: HIV positive, or other acquired or congenital immunodeficiency diseases; 10. Pregnant and lactating women; 11. People with idiopathic IgA deficiency; 12. Liver transplant patients; 13. IV and V degree hepatic encephalopathy; 14. Hepatorenal syndrome; 15. Patients with respiratory failure, breathing room air under resting conditions, and eliminating intracardiac anatomical shunts and reduced cardiac output, the arterial blood oxygen partial pressure (PaO2) is lower than 8kPa (60 mmHg), or accompanied by carbon dioxide partial pressure (PaCO2) is higher than 6.65 kPa (50 mmHg); 16. Patients with pulmonary hypertension; 17. Patients with pulmonary embolism or suspected pulmonary embolism; 18. Patients who plan to receive liver transplantation or have undergone liver transplantation queue up to receive liver transplantation during the trial period (within 6 months); 19. In the judgment of the investigator, subjects with history or current evidence of any disease, treatment or laboratory abnormalities that may confuse the study results, interfere with the subject's participation in the study procedure, or are not in the best interest of the subject's participation in the study are excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events;Dose limited toxicity (DLT);Survival time of patients without liver transplantation;Maximum tolerant dose (MDT); | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical improvement rate and deterioration rate;Sings and symptoms;Child score;Laboratory index;Model for end-stage liver disease (MELD); | — |
Countries
China
Contacts
Public ContactHan Zhibo
Tianjin Amcellgene Engineering Co., Ltd.
Outcome results
None listed