Dose-escalation studies of mesenchymal stromal cell therapy for decompensated liver cirrhosis: phase Ia/Ib results and immune modulation insights.

ABSTRACT: Decompensated liver cirrhosis (DLC) is characterized by severe liver dysfunction and immune dysregulation, posing significant treatment challenges. Mesenchymal stromal cell (MSC) therapy has shown promise in DLC treatment, but the optimal dosing strategies and dose-dependent therapeutic mechanisms in humans remain unclear, limiting its clinical application. We conducted sequential Phase Ia/Ib trials using a single-arm, dose-escalation design to evaluate the safety and tolerability of MSC therapy in DLC patients while also exploring its immunomodulatory effects and gathering preliminary therapeutic signals. In Phase Ia, four dose cohorts received a single dose of MSCs: 5.0 × 10⁷, 1.0 × 10⁸, 1.5 × 10⁸, and 2.0 × 10⁸ cells. Patients were followed up on Days 3, 7, 14, and 28. Multiomics analys

SUBMITTER: Shi L 

PROVIDER: S-EPMC12304480 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature