HCL001 Cell Injection for Decompensated Cirrhosis: A Phase I/II Trial

Inclusion Criteria: * Age ≥ 18 years at the time of informed consent; sex unrestricted. * Diagnosis of decompensated cirrhosis established according to the Chinese Guidelines for the Diagnosis and Treatment of Liver Cirrhosis (2019 Edition) and attributable to: hepatitis B, hepatitis C, alcohol, autoimmune disease, metabolic-associated fatty liver disease, or other less common aetiologies when deemed appropriate by the investigator. * Karnofsky Performance Status (KPS) ≥ 60 (see Appendix 6). * Presence of a vascular access route judged safe for selective catheterisation of the proper hepatic artery. * For subjects with hepatitis B or C cirrhosis: HBV-DNA ≤ 50 IU/mL and HCV-RNA below the limit of quantification at screening; for alcohol-related cirrhosis: documented abstinence for ≥ 6 months. * Ability to understand the study procedures and willingness to comply; written informed consent obtained from the subject or legally authorised representative. Exclusion Criteria: * Known hypersensitivity to HCL001 Cell Injection or any of its excipients. * Child-Pugh score ≥ 13 (see Appendix 1 for scoring and classification). * Cavernous transformation of the portal vein. * Serum total bilirubin \> 10 × the upper limit of normal (ULN). * Hepatocellular carcinoma or any other concurrent malignancy. * Inability to cooperate or unwillingness to comply with protocol requirements. * Bleeding diathesis (e.g., haemophilia) or platelet count \< 40 × 10⁹/L despite platelet-raising therapy. * Use of anticoagulant or antiplatelet agents within 7 days prior to dosing. * Grade ≥ 3 hepatic encephalopathy within 3 months before dosing (grading criteria in Appendix 2). * Previous transjugular intrahepatic portosystemic shunt (TIPS) or requirement/planned TIPS during the study. * History of venous thrombosis, including portal vein thrombosis (PVT) Grade ≥ 2 (grading criteria in Appendix 9), deemed unsuitable by the investigator. * Severe dysfunction of vital organs (heart, lung, brain, kidney): Pulmonary: severe emphysema, pulmonary embolism, or any pulmonary disorder significantly impairing pulmonary function. Cardiac history meeting any of the following: 1. Decompensated heart failure (NYHA Class III-IV); 2. Unstable angina within 6 months before dosing. Chronic kidney disease (CKD) Stage 4-5. * Inadequately controlled diabetes despite treatment: HbA1c ≥ 8 % or fasting plasma glucose ≥ 10 mmol/L. * Pregnancy or lactation women; or inability/unwillingness to use Investigator-approved contraceptive methods during the study and for 6 months after study completion. * Participation in another interventional clinical trial within 3 months before screening, or prior receipt of any stem-cell therapy. * Positive human immunodeficiency virus (HIV) antibody. * Active infection (defined as an infection, other than intra-abdominal, requiring intravenous antibiotics) within 2 weeks before screening, deemed unsuitable by the investigator. * Ascites with concurrent intra-abdominal infection \[defined as: 1. Positive ascitic fluid culture; or 2. Ascitic polymorphonuclear neutrophil (PMN) count ≥ 250 × 10⁶/L\], deemed by the Investigator as unsuitable for trial participation. * History of drug abuse or psychiatric disorders. * Any other condition or circumstance-including concomitant disease, therapy, procedure, surgery, or clinically significant laboratory abnormality-that, in the opinion of the investigator, could interfere with study conduct, impose additional risk to the subject, or preclude safe participation or completion of the study.