Efficacy and Safety of Allogeneic Human Bone Marrow Mesenchymal Stem Cells for the Treatment of Patients with Acute-on-chronic Liver Failure

What this Trial Is About

Researchers are evaluating the safety and initial effectiveness of CG-BM1, an allogeneic human bone marrow mesenchymal stem cell injection, for adults with acute-on-chronic liver failure (ACLF). This trial aims to treat patients with ACLF by observing how well CG-BM1 can improve liver function and reduce inflammation, based on promising preclinical studies. It is a two-phase study including dose escalation and randomized, placebo-controlled testing to guide further clinical development. The study includes two phases: Phase I uses an open-label, dose-escalation design with three dose groups, where patients receive a single infusion of CG-BM1 at different doses and are monitored for safety. Phase II is a multicenter, randomized, double-blind, placebo-controlled trial with two dose groups selected from Phase I results. In Phase II, patients receive four weekly intravenous infusions of CG-BM1 or placebo alongside conventional treatments such as antiviral therapy and nutritional support. Participants will undergo detailed monitoring including laboratory tests for liver function markers, immune factors, and organ failure scores at multiple time points up to 180 days after the first dose. Researchers will track adverse events, liver transplant-free survival, and changes in liver stiffness and blood tests to assess safety and preliminary treatment effects. The total participation duration includes intensive follow-up visits after infusion to ensure comprehensive evaluation of outcomes and potential side effects.

Efficacy and Safety of BMSCs (CG-BM1) for ACLF Patients