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Clinical Trials in China / NCT05035108
Recruiting Early Phase 1

The Treatment of Bioartificial Liver With hiHep Cells After Extensive Hepatectomy

NCT05035108 · tracked via the Priya Life Science China tracker
Sponsor
Sir Run Run Shaw Hospital
Phase
Early Phase 1
Started
2021-09-05
Last updated
2025-06-26

Condition(s) studied

Hepatoma Resectable

Investigational drug(s) / intervention(s)

hiHep bioartificial liver therapy

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.

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.

Eligibility

Sex
ALL
Min age
30 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Diagnosed as liver cancer, hepatolithiasis, benign liver tumor, with clear indications for liver resection; 2. Liver function Child A-B; 3. There is no contraindication to surgery for cardiopulmonary function; 4. The expected remaining liver volume/standard liver volume is less than 50%; Exclusion Criteria: 1. In the late stage of the disease, patients with frequent symptoms such as cerebral edema accompanied by cerebral herniation and clinical evidence indicating intracranial hemorrhage; 2. PaO2/FiO2 is less than 200 and cannot be corrected; 3. Patients with diffuse intravascular coagulation; 4. Those with active bleeding; 5. Uncontrolled infection; 6. The platelet count is less than 50,000/μL and cannot be corrected; 7. There is no blood vessel available for dialysis treatment; 8. HIV, HDV or HCV positive; 9. Drug abuse within 1 year; 10. Those with severe systemic circulatory failure; 11. Those who are highly allergic to the drugs used in the treatment process, such as plasma, heparin, protamine, etc.; 12. Combined pregnancy; 13. Patients with hepatorenal syndrome; 14. Patients with autoimmune liver disease; 15. Patients with non-alcoholic fatty liver and hereditary liver diseases (Wilson syndrome and a-antitrypsin deficiency); 16. Other conditions that the clinician believes cannot tolerate the treatment.

Primary outcome measure(s)

  • The incidence of adverse events (safety and tolerability). — 3 months after therapy
    Record adverse events (AE), serious adverse events (SAE), and AEs (TEAE) that occurred during treatment.

Trial sites (1)

FacilityCityRegionStatus
Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital Hangzhou Zhejiang Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05035108 on ClinicalTrials.gov ↗ ← All trials in China