The goal of this clinical trial is to evaluate the safety and tolerability of multiple doses of human umbilical cord mesenchymal stem cell injection in patients with decompensated hepatitis B cirrhosis, and to further explore the efficacy, pharmacodynamic profile and appropriate dose of administration to provide a basis for the use of safer and more effective treatments for patients with decompensated hepatitis B cirrhosis in the future.
Participants are required to sign an informed consent form and, after undergoing a series of tests and meeting the protocol's entry and exclusion criteria, are assigned to a dose group for intravenous infusion of human umbilical cord mesenchymal stem cells.
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
other causes of cirrhosis, such as alcoholic hepatitis, viral hepatitis C, autoimmune hepatitis and metabolic-related fatty liver disease
Child-Pugh score >12;
History of malignancy of the liver or other organs, or a family history of liver malignancy in three generations of immediate family members;
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;
Sequential
Human Umbilical Cord Mesenchymal Stem Cells
Biological/VaccineThe stem cell infusion route is peripheral intravenous infusion, once every 4 weeks for a total of 3 infusions. All subjects received experimental drugs and conventional treatment during the study period.
Adverse Event (AE)
Adverse events that occurred during the trials
Serious Adverse Event (SAE)
Serious adverse events that occurred during the trial
Recommended dose for phase 2 clinical trial (RP2D)
Recommended dose for phase 2 clinical trial
Dose-limiting toxicity (DLT)
Dose-limiting toxicity
Overall survival
Time of survival
Rate of survival
Rate of survival without liver transplantation
Child-Pugh
The Child-Pugh score included a score for five indicators: hepatic encephalopathy, ascites, total bilirubin concentration, albumin concentration, and prothrombin time extension. For each indicator, the lowest score is 1, the highest score is 3, and the total score of each indicator is calculated. A higher score indicates more severe disease.
MELD
The Model for End-stage Liver Disease is a scoring system based on serum creatinine, international standardized ratio, total bilirubin combined with the cause of cirrhosis to evaluate the liver function reserve and prognosis of patients with chronic liver disease. Calculating formula for R = 3.78 \* ln \[T - Bil (umol/L) / 17.1\] ln (INR) + 9.57 + 11.2 \* \* ln Cr (umol/L) / 88.4 + 6.43 \* the etiology. (Etiology: 0 for cholestatic cirrhosis and alcoholic cirrhosis, 1 for viral and other causes)
IL-1β (Interleukin-1β)
The concentration of IL-1β
IL-6 (Interleukin-6)
The concentration of IL-6
IL-8 (Interleukin-8)
The concentration of IL-8
IL-8 (Interleukin-10)
The concentration of IL-10
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