肝切除是原发性肝癌的一线治疗，具有潜在的治愈潜力。然而，对于术后肝衰竭（PHLF）的担忧是限制符合条件患者人数的主要原因。在此，我们采用在GMP条件下制造的人诱导肝细胞（hiHeps）制造了一种临床级生物人工肝（BAL）装置。在猪的PHLF模型中，hiHep-BAL治疗显示了显著的生存益处。除支持作用外，hiHep-BAL治疗还恢复了残留肝的特定功能，特别是氨解毒功能，并促进了肝再生。值得注意的是，对于接受扩大肝切除手术的七名患者的调查者发起的研究表明，hiHep-BAL治疗耐受性良好，与改善肝功能和肝再生相关，达到了安全和可行性的主要结果。这些令人鼓舞的结果证明了进一步测试hiHep-BAL治疗PHLF的必要性，其成功将扩大接受肝切除手术的患者人数。版权所有© 2023 The Authors。Elsevier Inc.保留所有权利。

Liver resection is the first-line treatment for primary liver cancers, providing the potential for a cure. However, concerns about post-hepatectomy liver failure (PHLF), a leading cause of death following extended liver resection, have restricted the population of eligible patients. Here, we engineered a clinical-grade bioartificial liver (BAL) device employing human-induced hepatocytes (hiHeps) manufactured under GMP conditions. In a porcine PHLF model, the hiHep-BAL treatment showed a remarkable survival benefit. On top of the supportive function, hiHep-BAL treatment restored functions, specifically ammonia detoxification, of the remnant liver and facilitated liver regeneration. Notably, an investigator-initiated study in seven patients with extended liver resection demonstrated that hiHep-BAL treatment was well tolerated and associated with improved liver function and liver regeneration, meeting the primary outcome of safety and feasibility. These encouraging results warrant further testing of hiHep-BAL for PHLF, the success of which would broaden the population of patients eligible for liver resection.Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.