The Treatment of Bioartificial Liver With hiHep Cells After Extensive Hepatectomy

Official title

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

Overview

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.

Detailed description

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.

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)

Primary outcome measures

• The incidence of adverse events (safety and tolerability). [Time frame: 3 months after therapy]

Secondary outcome measures (7)

• Patient's recovery of liver function [Time frame: 1day,3day,7day,1month,3 months after therapy]
• Rate of liver proliferation [Time frame: 7day,1month,3 months after therapy]
• Incidence of liver failure [Time frame: 1day,3day,7day,1month,3 months after therapy]
• Complication rate [Time frame: 1day,3day,7day,1month,3 months after therapy]
• Immunoinflammatory index [Time frame: 1day,3day,7day,1month,3 months after therapy]
• Renal function [Time frame: 1day,3day,7day,1month,3 months after therapy]
• Electrolyte level [Time frame: 1day,3day,7day,1month,3 months after therapy]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw H — Hangzhou

Identifiers

NCT: NCT05035108 · SRRSH20201110-8

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗