The Treatment of Bioartificial Liver With hiHep Cells After Extensive Hepatectomy

NCT05035108 | Recruiting Early Phase 1

• 1 other identifier: SRRSH20201110-8
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

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

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

  3 months after therapy

Secondary Outcomes (7)

• Patient's recovery of liver function

  1day,3day,7day,1month,3 months after therapy

• Rate of liver proliferation

  7day,1month,3 months after therapy

• Incidence of liver failure

  1day,3day,7day,1month,3 months after therapy

• Complication rate

  1day,3day,7day,1month,3 months after therapy

• Immunoinflammatory index

  1day,3day,7day,1month,3 months after therapy

Study Arms (1)

extensive hepatectomy patient

EXPERIMENTAL

hiHep bioartificial liver therapy

Biological: hiHep bioartificial liver therapy

Interventions

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.

extensive hepatectomy patient

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%;

You may not qualify if:

• 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);

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead
• Hexaell Biotech Co., Ltd.: collaborator

Study Sites (1)

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

Hangzhou, Zhejiang, 310000, China

RECRUITING

Study Officials

• Yifan Wang, MD

  Sir Run Run Shaw Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiujun Cai, MD

CONTACT

0086-0571-86006605; caixiujunzju@yahoo.com.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The director of Sir Run Run Shaw Hospital

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: September 5, 2021
• Study Start: September 5, 2021
• Primary Completion (Estimated): November 30, 2030
• Study Completion (Estimated): November 30, 2030
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)