Safety of Umbilical Cord Mesenchymal Stem Cells (UC-MSC) in Patients With Decompensated Hepatitis B Cirrhosis

Korábbi kezelés

• Recent uncontrolled gastrointestinal bleeding (e.g., severe bleeding tendency or active bleeding within 3 months prior to screening, or clinically significant upper gastrointestinal hemorrhage event within 4 weeks prior to screening), as determined by the investigator to be unsuitable for participation in this trial;
• Have had hepatic encephalopathy or hepatorenal syndrome within 3 months prior to screening
• Spontaneous peritonitis or a more severe active infection within 2 weeks prior to the trial
• Drug addicted or alcohol abusers;
• History of a serious mental disorder, including uncontrolled major depression or controlled or uncontrolled psychosis, within 24 months prior to screening;
• Those who have participated in other interventional clinical trials within 3 months prior to screening or are participating in other interventional clinical trials, or who have received prior stem cell therapy
• Those who are proposed for liver transplantation within 3 months;

Más betegség

• other causes of cirrhosis, such as alcoholic hepatitis, viral hepatitis C, autoimmune hepatitis and metabolic-related fatty liver disease
• History of malignancy of the liver or other organs, or a family history of liver malignancy in three generations of immediate family members;
• Those who have the history of venous thrombosis or pulmonary embolism
• Persons with a history of severe drug allergy or hypersensitivity;
• Other conditions that, in the opinion of the investigator, are not suitable for participation in this clinical trial.

Laborértékek

• Current serious medical conditions that would affect your safety and treatment efficacy assessment as determined by the investigator, such as: Class II or higher abnormal cardiac function (NYHA criteria), cardiovascular disease such as ischemic heart disease (e.g., myocardial infarction or angina), poorly controlled diabetes (fasting glucose ≥ 10 mmol/L or glycated hemoglobin (HbA1c) ≥ 8%), serum creatinine \> 2 times the upper limit of normal (ULN), etc;
• Positive infectious disease test (serum anti-HIV antibody, anti-HCV antibody, syphilis antibody either positive) or active tuberculosis;
• Those who have received human albumin within 3 weeks prior to the first infusion of the test drug;

Egyéb

• Child-Pugh score \>12;
• Women who are pregnant or breastfeeding;

• 18 to 75 years old (including borderline values) at screening, regardless of gender
• Diagnosed with decompensated hepatitis B cirrhosis according to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2019 edition)
• There's no significant reduction in cirrhotic symptoms or no significant improvement in quality of life score after more than 3 months of strict medical conservative treatment
• HBV DNA ≤ 1000 IU/mL at the time of screening
• Fully understand the informed consent form, voluntarily subject to the trial and sign the informed consent form.