RecruitingEarly Phase 1NCT05035108

The Treatment of Bioartificial Liver With hiHep Cells After Extensive Hepatectomy

A Clinical Study of hiHep Cells for Bioartificial Liver After Extensive Hepatectomy


Sponsor

Sir Run Run Shaw Hospital

Enrollment

10 participants

Start Date

Sep 5, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 30 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a bioartificial liver support device — using specially grown human liver cells — to help patients recover after major liver removal surgery where a large portion of the liver is taken out. **You may be eligible if...** - You have liver cancer, liver stones, or a benign liver tumor requiring surgery - Your liver function is reasonably good (Child-Pugh class A or B) - Your heart and lungs are healthy enough for surgery - Your remaining liver after surgery is expected to be less than 50% of normal size **You may NOT be eligible if...** - You have severe brain swelling or signs of bleeding in the brain - You have a serious blood clotting disorder or active bleeding - You have HIV, hepatitis D, or hepatitis C - You have kidney failure related to your liver disease - You have an autoimmune liver disease, fatty liver disease, or certain inherited liver conditions - You are pregnant - You have used drugs in the past year - You have a severe allergy to plasma, heparin, or protamine Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALhiHep 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.


Locations(1)

Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

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NCT05035108