Project description:Interventions: Antibiotics
Without antibiotics
Primary outcome(s): The rate of post electrocoagulation syndrome after colorectal endoscopic submucosal dissection
Study Design: Parallel Randomized
Project description:Interventions: Non-closure
Endoscopic closure
Primary outcome(s): The rate of PECS and delayed perforation
Study Design: Parallel Randomized
Project description:Here, we developed a clinical-grade bioartificial liver (BAL) device by implanting with directly reprogrammed human hepatocytes (hiHep) manufactured and cryopreserved under current good manufacturing practice (cGMP) conditions. Notably, in a porcine PHLF model induced by 85% hepatectomy, hiHep-BAL treatment showed a remarkable survival benefit, as well as improvements of liver metabolic gene expression, ammonia detoxification, and liver regeneration. Furthermore, an investigator-initiated study in seven patients with extended liver resection (NCT05035108) demonstrated that hiHep-BAL treatment was well tolerated without complications and associated with ameliorative liver function and remarkable liver regeneration, meeting the primary outcome of safety and feasibility. These encouraging results warrant the further efficacy testing of hiHep-BAL for PHLF followed by the future broadening the patients eligible for liver resection in clinics.