Clinical Trial

The Treatment of Bioartificial Liver With hiHep Cells After Extensive Hepatectomy

Recruiting Early Phase 1
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Summary
It is a prospective, non-randomized, single-arm cohort study. A total of 10 patients will be included in this study. Based on standardized treatment, the treatment of bioartificial liver device will be applied 48-72 hours after extensive hepatectomy. The bioartificial liver device consists of clinical-grade human-induced hepatocytes (hiHep) generated from human fibroblasts via transdifferentiation. In order to evaluate the security and effectiveness of the device, liver function, liver volume, the incidence of liver failure and other results will be analyzed.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2021-09-02; most recent amendment 2025-06-23.
Trial Details
NCT Number NCT05035108
Lead Sponsor Sir Run Run Shaw Hospital
Collaborators: Hexaell Biotech Co., Ltd.
Conditions Hepatoma Resectable
Enrollment 10 participants
Start Date 2021-09-05
Primary Completion 2030-11-30 (estimated)
Study Completion 2030-11-30 (estimated)
Updated on ClinicalTrials.gov 2025-06-26