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

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.