The Treatment of Bioartificial Liver With hiHep Cells After Extensive Hepatectomy

A Clinical Study of hiHep Cells for Bioartificial Liver 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 24-48 hours after extensive hepatectomy. 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.

Study Overview

• Status: Recruiting
• Conditions: Hepatoma Resectable
• Intervention / Treatment: Biological: hiHep bioartificial liver therapy

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 24-48 hours Hemodialysis tube, then take artificial liver treatment which lasts 6-9h, 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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Xiujun Cai, MD; Phone Number: 0086-0571-86006605; Email: caixiujunzju@yahoo.com.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital
      • Contact: Xiujun Cai, MD; Phone Number: 0086-0571-86006605; Email: caixiujunzju@yahoo.com.cn
      • Contact: Hanning Ying, MS; Phone Number: 0086-0571-86006276; Email: henry_yinghn@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: extensive hepatectomy patient; hiHep bioartificial liver therapy

Biological: hiHep bioartificial liver therapy; HiHep cell bioartificial liver treatment was performed 24-48 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 6-9h.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's recovery of liver function	Through child-pugh liver function grading standard and changes in ALT, AST, AKP, r-GGT, TBil, DBil, ALB to evaluate liver function.	1day,3day,7day,1month,3 months after therapy
Rate of liver proliferation	Remaining liver growth rate (calculation of residual liver volume based on CT three-dimensional reconstruction).	7day,1month,3 months after therapy
Incidence of liver failure	Use Guidelines for The Diagnosis and Treatment of Liver Failure (exclude liver failure caused by surgical hemodynamic problems).	1day,3day,7day,1month,3 months after therapy
Complication rate	Such as pleural effusion, hydrops abdominis, hemorrhage, bile leakage.	1day,3day,7day,1month,3 months after therapy
Immunoinflammatory index	Changes in PCT, hCRP, immune globulin (IgA, IgM, IgG), complement (C3, C4) after the treatment.	1day,3day,7day,1month,3 months after therapy
Renal function	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.	1day,3day,7day,1month,3 months after therapy
Electrolyte level	Changes in the concentration of Na+, K+, Cl+, Ca+ in blood before and after treatment.	1day,3day,7day,1month,3 months after therapy

Collaborators and Investigators

• Sponsor: Sir Run Run Shaw Hospital
• Collaborators: Hexaell Biotech Co., Ltd
• Investigators: Principal Investigator: Yifan Wang, MD, Sir Run Run Shaw Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2020
• Primary Completion (Anticipated): November 30, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: May 31, 2021
• First Submitted That Met QC Criteria: September 2, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): September 13, 2021
• Last Update Submitted That Met QC Criteria: September 4, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma, Hepatocellular
• Other Study ID Numbers: SRRSH20201110-8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No