Decompensated Liver Cirrhosis
Conditions
Interventions
low dose group:standard of care (SOC) plus 5x10^7 MSC cells
medium dose group:standard of care (SOC) plus 1 x10^8 MSC cells
high dose group:standard of care (SOC) plus 1.5x10^8 MSC cells
Sponsors
The Fifth Medical Center of PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent; 2. Aged 18 to 75 years (including 18 and 75 years old), gender is not limited; 3. Diagnosed as decompensated cirrhosis based on clinical manifestations, laboratory tests, imaging findings and/or representative pathological findings (Decompensated cirrhosis is defined as at least one serious complication, including esophagogastric varices bleeding, hepatic encephalopathy, ascites, spontaneous bacterial peritonitis and other serious complications); 4. Child-Pugh score is 7-12 points (including the boundary value).
Exclusion criteria
Exclusion criteria: 1. Serious complications such as esophagogastric variceal bleeding, grade 2 or above hepatic encephalopathy, refractory ascites, and hepatorenal syndrome occurred within 1 month; 2. 2 weeks of uncontrolled serious infection; 3. Hepatitis B virus (HBV) DNA >= detection limit; 4. Patients with hepatitis B cirrhosis may discontinue antiviral therapy during the study, or receive anti-HBV therapy for less than 12 months; 5. Patients with hepatitis C cirrhosis may discontinue antiviral therapy during the study, or receive antiviral therapy for less than 12 months; 6. Patients with autoimmune cirrhosis receiving glucocorticoid therapy for less than 6 months; 7. Received transjugular intrahepatic portosystemic shunt (TIPS) for less than 6 months; 8. Unwilling to stop drinking after being included in the study; 9. Severe jaundice (serum total bilirubin level >= 170 µmol/L); obvious renal insufficiency (serum creatinine >= 1.2 times the upper limit of normal); severe electrolyte abnormalities (serum sodium level < 125 mmol/l); severe leukopenia (leukocyte count < 1 x 10^9/L); 10. Patients with biliary obstruction, or with hepatic vein, portal vein, or splenic vein thrombosis, or cavernous degeneration of portal vein; 11. Those with a history of surgical operations such as splenectomy or portosystemic shunt; 12. Diagnosed or suspected combined malignant tumor; 13. Those with a history of major organ transplantation or those with serious heart, lung, kidney, blood, endocrine and other system diseases; 14. Patients who use drugs, receive methadone treatment, have drug dependence or mental illness; 15. Human immunodeficiency virus (HIV) antibody test results are positive; 16. Those who have received blood transfusion and other blood products within 1 month; 17. Pregnant, lactating patients or those who have a childbearing plan in the near future; 18. Those with allergic constitution or a history of severe allergies; 19. Those who have participated in other clinical trials within the past 3 months; 20. Other conditions in which the patient is considered unsuitable to participate in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 28-day change from baseline in the Model for End-Stage Liver Disease (MELD) score;Incidence of adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in MELD score;Incidence of each complication associated with decompensated cirrhosis;Liver transplant-free survival;Incidence of liver failure;Laboratory examination;Child-Turcotte-Pugh (CTP) score;Quality of life assessment;Incidence of liver cancer; | — |
Countries
China
Contacts
Public ContactWang Fusheng
The Fifth Medical Center of PLA General Hospital
Outcome results
None listed