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

A single SRC will be convened during the Phase I dose-escalation stage to conduct dynamic safety oversight. The SRC will comprise investigators, the Sponsor, and/or medically qualified personnel designated by the Sponsor's delegate (contract research organization \[CRO\]). Detailed SRC procedures are provided in a separate SRC charter. * Begin with three subjects in the lowest cohort. * If zero of three subjects experience a DLT during the observation period, escalate to the next cohort. * If one of three subjects experiences a DLT, enroll an additional three subjects at the same dose level. * If ≤ 1/6 total subjects in the expanded cohort experience a DLT, escalate to the next cohort. * If \> 1/6 experience a DLT, dose escalation is terminated. * If ≥ 2 of the initial three subjects experience a DLT, escalation is stopped; the preceding dose level is declared the maximum tolerated dose (MTD). * If \> 1 subject experiences a DLT at any dose level, no further escalation will occur per protocol, and the preceding cohort will be designated the MTD. * If no DLT is observed at the highest predefined dose (4 × 10⁶ cells/kg), the investigator and the Sponsor will jointly determine whether exploration of higher doses is warranted. Upon completion of the Week 12 assessment in the last subject enrolled in Phase I, one or two dose levels will be selected for Phase II expansion based on the safety and preliminary efficacy data obtained during Phase I. Eligible subjects will be randomized to an investigational arm or a control arm. * If only one investigational dose is selected, the randomization ratio will be investigational arm : control arm = 2 : 1. * If two investigational doses are selected, the randomization ratio will be low-dose group : high-dose group : control group = 2 : 2 : 1. Each investigational cohort will enroll 20-30 subjects, and the control cohort will enroll 10-15 subjects; the control group will receive standard-of-care treatment only. The total anticipated enrollment for Phase II is 30-75 subjects.