Preclinical efficacy and safety evaluation of human embryonic stem cell-derived functional hepatocytes for a clinical trial in acute liver failure - PubMed
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- #clinical-trial
- Human embryonic stem cell-derived hepatocyte-like cells (HPLCs) show promise for treating acute liver failure (ALF).
- A GMP-compliant process was developed to generate HPLCs with mature hepatocyte functions, including metabolism and albumin secretion.
- Preclinical studies demonstrated HPLCs improved survival rates in ALF rats (72.4% via tail vein, 66.7% via intraperitoneal injection).
- HPLCs met safety standards with no acute toxicity or tumorigenicity, supporting their clinical use.
- A Phase I clinical trial (ChiCTR2100052988) for ALF and acute-on-chronic liver failure (ACLF) has been approved and initiated.