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NCT Number: NCT05035108

The Treatment of Bioartificial Liver With hiHep Cells After Extensive Hepatectomy

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.

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Key information

Conditions

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

About this study

Include large-scale hepatectomy patients who meet the Inclusion criteria into the experimental group. Patient will be sent to ICU monitoring after surgery , the investigators will evaluate the blood routine, liver and kidney function, blood coagulation function, and immune inflammation indicators on the first day after surgery, and large veins will be temporarily indwelled within 48-72 hours Hemodialysis tube, then take artificial liver treatment which lasts 4-6h, follow-up test results on the 1st day, 3rd day, 7th day, 1 month and 3 months about blood routine, liver and kidney function, coagulation function, blood ammonia, Immune inflammation indicators, imaging examinations (CT or MR) at 7 days, 1 month and 3 months after treatment, to evaluate the recovery of liver function and liver regeneration after artificial liver treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed as liver cancer, hepatolithiasis, benign liver tumor, with clear indications for liver resection;
  • Liver function Child A-B;
  • There is no contraindication to surgery for cardiopulmonary function;
  • The expected remaining liver volume/standard liver volume is less than 50%;

Exclusion criteria

  • 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;
  • PaO2/FiO2 is less than 200 and cannot be corrected;
  • Patients with diffuse intravascular coagulation;
  • Those with active bleeding;
  • Uncontrolled infection;
  • The platelet count is less than 50,000/μL and cannot be corrected;
  • There is no blood vessel available for dialysis treatment;
  • HIV, HDV or HCV positive;
  • Drug abuse within 1 year;
  • Those with severe systemic circulatory failure;
  • Those who are highly allergic to the drugs used in the treatment process, such as plasma, heparin, protamine, etc.;
  • Combined pregnancy;
  • Patients with hepatorenal syndrome;
  • Patients with autoimmune liver disease;
  • Patients with non-alcoholic fatty liver and hereditary liver diseases (Wilson syndrome and a-antitrypsin deficiency);
  • Other conditions that the clinician believes cannot tolerate the treatment.

Treatment and study plan

hiHep bioartificial liver therapy

Biological

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.

Primary outcomes

  1. The incidence of adverse events (safety and tolerability).

    Time frame: 3 months after therapy

    Record adverse events (AE), serious adverse events (SAE), and AEs (TEAE) that occurred during treatment.

Secondary outcomes

  1. Patient's recovery of liver function

    Time frame: 1day,3day,7day,1month,3 months after therapy

    Through child-pugh liver function grading standard and changes in ALT, AST, AKP, r-GGT, TBil, DBil, ALB to evaluate liver function.

  2. Rate of liver proliferation

    Time frame: 7day,1month,3 months after therapy

    Remaining liver growth rate (calculation of residual liver volume based on CT three-dimensional reconstruction).

  3. Incidence of liver failure

    Time frame: 1day,3day,7day,1month,3 months after therapy

    Use Guidelines for The Diagnosis and Treatment of Liver Failure (exclude liver failure caused by surgical hemodynamic problems).

  4. Complication rate

    Time frame: 1day,3day,7day,1month,3 months after therapy

    Such as pleural effusion, hydrops abdominis, hemorrhage, bile leakage.

  5. Immunoinflammatory index

    Time frame: 1day,3day,7day,1month,3 months after therapy

    Changes in PCT, hCRP, immune globulin (IgA, IgM, IgG), complement (C3, C4) after the treatment.

  6. Renal function

    Time frame: 1day,3day,7day,1month,3 months after therapy

    Record the changes in creatinine and urea nitrogen, calculate GFR through MDRD or CKD-EPI formula to evaluate renal function by classification standards for renal insufficiency.

  7. Electrolyte level

    Time frame: 1day,3day,7day,1month,3 months after therapy

    Changes in the concentration of Na+, K+, Cl+, Ca+ in blood before and after treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiujun Cai, MD

CONTACT

[email protected]

0086-0571-86006605

Sponsors and collaborators

Lead sponsor

Sir Run Run Shaw Hospital

Other

Collaborators

  • Hexaell Biotech Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2030
Study completion
2030
First posted
Sep 5, 2021
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.