Human Umbilical Cord-derived Mesenchymal Stem Cells for Decompensated Cirrhosis (MSC-DLC-2)

Exclusion Criteria21

• Appearance of active variceal bleeding, overt hepatic encephalopathy (HE), refractory ascites or hepatorenal syndrome within 1 month prior to screening visit.
• Uncontrolled severe infection within 2 weeks of screening.
• Patients with hepatitis B virus-related decompensated liver cirrhosis may discontinue antiviral therapy during the study, or those who with antiviral therapy for HBV for less than 12 months, or hepatitis B virus (HBV) DNA ≥ detection limit at the time of screening.
• Patients with hepatitis C virus-related decompensated liver cirrhosis may discontinue antiviral therapy during the study, or those who with antiviral therapy for HCV for less than 12 months, or hepatitis C virus (HCV) RNA ≥ detection limit at the time of screening (except HCV RNA< detection limit without any antiviral treatment).
• Patients under treatment with corticosteroids for autoimmune hepatitis for less than 6 months.
• Trans-jugular intrahepatic portosystemic shunts (TIPS) insertion within 6 months prior to study inclusion.
• Active drinkers with alcohol-related decompensated cirrhosis are unwilling to stop alcohol abuse after inclusion.
• Significant renal insufficiency (serum creatinine ≥ 1.2 times upper normal limit); Severe electrolyte abnormality (serum sodium level < 125 mmol/L); Severe leukopenia (white blood cell count < 1 × 10E9/L).
• Patients with biliary obstruction, or portal vein spongiosis.
• Patients with surgical history such as splenic cut-off flow.
• Patients with malignant tumors within 5 years, except those with basal cell carcinoma, squamous cell carcinoma and/or carcinoma in situ who had received curative treatment and curative resection.
• Patients with a prior history of major organ transplantation or complicated with significant disease of heart, lung, kidney, blood, endocrine and other systems.
• Drug abuse, drug dependence and patients who receive methadone treatment or with psychosis.
• Against the human immunodeficiency virus antibody (Anti - HIV) or syphilis antibody test results were positive.
• Pregnancy, lactation or with recent fertility plan during the test and 6 months after the test.
• Highly allergic, or have a history of severe allergies, known severe allergies to the investigational drug or any of the excipients.
• History of pulmonary embolism.
• Patients who had previously received stem cell therapy or were intolerant to cell therapy.
• The proposed line of liver transplants within three months.
• Participants in other clinical trials within the last 3 months.
• Any other clinical condition which the investigator considers would make the patient unsuitable for the trial.