This study protocol is designed to evaluate the clinical efficacy, safety, and tolerability of HCL001 cell injection in the treatment of decompensated cirrhosis. The aim is to provide stronger evidence for the clinical application of HCL001 cell injection in the treatment of decompensated cirrhosis, thereby attempting to improve patients' survival and quality of life to meet the clinical needs for treating decompensated liver cirrhosis.
When signing the informed consent form, individuals between the ages of 18 to 75 years (inclusive, including the boundary values) are eligible, and there are no restrictions based on gender.
According to the "Guidelines for the Diagnosis and Treatment of Cirrhosis (2019 Edition)", a diagnosis of decompensated cirrhosis is made.
A Child-Pugh score of 7-12 points (including the threshold) is classified as [insert the corresponding classification as per the provided appendix].
An ECOG performance status score of 0-2 or a Karnofsky Performance Status (KPS) score greater than 60 is considered [insert the corresponding classification or interpretation].
Allergic individuals, especially those allergic to any component of HCL001 cell injection or its excipients.
Individuals with concurrent liver cancer or other malignant tumors.
Patients who are unable or unwilling to cooperate or comply with the requirements of the research protocol.
International Normalized Ratio (INR) >2.5 and platelet count (PLT) less than 30 x 10^9/L.
Single group
HCL001 cell (homologous allogeneic hepatocytes) injection
DrugThe patient will undergo a DSA procedure in the hospital's operating room before infusion. A catheter will be inserted into the femoral artery and guided to the hepatic artery. Upon confirmation through imaging, HCL001 cell injection will be slowly infused through the catheter. During the infusion, the cells should be continuously agitated to prevent clumping. The infusion can be administered as a single dose or multiple doses, and after infusion, the patient will be closely monitored for at least one week.
Types and incidence of treatment-related adverse events.
Recording the types and incidence of treatment-related adverse events.
Dose-Limiting Toxicity (DLT)
Recording the Dose-Limiting Toxicity (DLT) . If one or more instances of Dose-Limiting Toxicity (DLT) occur, the dose escalation according to the original plan will be stopped, and the previous dose level will be determined as the Maximum Tolerated Dose (MTD).
Maximum Tolerated Dose (MTD)
Recording Maximum Tolerated Dose (MTD).If one or more instances of Dose-Limiting Toxicity (DLT) occur, the dose escalation according to the original plan will be stopped, and the previous dose level will be determined as the Maximum Tolerated Dose (MTD).
Child-Pugh grading.
Child-Pugh scoring is a scoring system used to assess the liver function and prognosis of patients with cirrhosis, typically used to evaluate the severity of liver disease in patients. Child-Pugh scoring is based on several indicators of the patient, including the following five indicators: Total bilirubin levels Albumin levels Coagulation function (prothrombin time or PT) Degree of Ascites Presence of hepatic encephalopathy Child-Pugh scoring assesses the above five indicators and classifies patients into three grades A, B, or C, representing mild, moderate, and severe conditions respectively. A higher score indicates more severe liver dysfunction. Child-Pugh scoring is primarily used to evaluate the liver function and prognosis of patients with liver disease, assisting physicians in developing treatment plans and assessing the severity of the patients' conditions.
Number of participants with abnormal laboratory tests results
Objective laboratory tests/examinations (ALT, AST, TBIL, DBIL, TP, ALB, GLB, Hb, white blood cell count, and platelet count.)
The percentage of participants with improved liver conditions (including changes in portal vein diam
Ultrasound examination
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