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The Treatment of Bioartificial Liver With hiHep Cells After Extensive Hepatectomy

NCT05035108 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-06-26

No results posted yet for this study

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.

Conditions

  • Hepatoma Resectable

Interventions

BIOLOGICAL

hiHep bioartificial liver therapy

HiHep cell bioartificial liver treatment was performed 48-72 hours after extensive hepatectomy. Temporary hemodialysis tube for large vein (jugular vein or femoral vein) is indwelled before treatment. Before treatment, prepare hiHeps-BAL in a biological safety cabinet that meets clinical standards, connect the corresponding tubing to the Jianfan DX-10 blood purification machine, and prefill with heparin saline. Half an hour before treatment, the patient was pre-heparinized (heparin about 600iu) and dexamethasone to prevent allergic reactions. The patient enters the ICU, the monitor is connected to the corresponding pipeline, the arterial pump 120-160ml/min, the slurry pump 30-40ml/min, the circulating pump 75-100ml/min, the duration is 4-6h.

Sponsors & Collaborators

  • Hexaell Biotech Co., Ltd.

    collaborator INDUSTRY

  • Sir Run Run Shaw Hospital

    lead OTHER

Principal Investigators

  • Yifan Wang, MD · Sir Run Run Shaw Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-05
Primary Completion
2030-11-30
Completion
2030-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05035108 on ClinicalTrials.gov