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The Treatment of Bioartificial Liver With hiHep Cells After Extensive Hepatectomy

Primary Purpose

Hepatoma Resectable

Status

Unknown status

Phase

Early Phase 1

Locations

China

Study Type

Interventional

Intervention

hiHep bioartificial liver therapy

About this trial

This is an interventional treatment trial for Hepatoma Resectable

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

extensive hepatectomy patient

Arm Description

hiHep bioartificial liver therapy

Outcomes

Primary Outcome Measures

The incidence of adverse events (safety and tolerability).

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

Secondary Outcome Measures

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.

Rate of liver proliferation

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

Incidence of liver failure

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

Complication rate

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

Immunoinflammatory index

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

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.

Electrolyte level

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

Full Information

NCT ID

NCT05035108

First Posted

May 31, 2021

Last Updated

September 4, 2021

Sponsor

Sir Run Run Shaw Hospital

Collaborators

Hexaell Biotech Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05035108

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

November 10, 2020 (Actual)

Primary Completion Date

November 30, 2021 (Anticipated)

Study Completion Date

December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sir Run Run Shaw Hospital

Collaborators

Hexaell Biotech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatoma Resectable

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

extensive hepatectomy patient

Arm Type

Experimental

Arm Description

hiHep bioartificial liver therapy

Intervention Type

Biological

Intervention Name(s)

hiHep bioartificial liver therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

The incidence of adverse events (safety and tolerability).

Description

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

Time Frame

3 months after therapy

Secondary Outcome Measure Information:

Title

Patient's recovery of liver function

Description

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

Time Frame

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

Title

Rate of liver proliferation

Description

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

Time Frame

7day,1month,3 months after therapy

Title

Incidence of liver failure

Description

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

Time Frame

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

Title

Complication rate

Description

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

Time Frame

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

Title

Immunoinflammatory index

Description

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

Time Frame

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

Title

Renal function

Description

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.

Time Frame

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

Title

Electrolyte level

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiujun Cai, MD

Phone

0086-0571-86006605

caixiujunzju@yahoo.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yifan Wang, MD

Organizational Affiliation

Sir Run Run Shaw Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiujun Cai, MD

Phone

0086-0571-86006605

caixiujunzju@yahoo.com.cn

First Name & Middle Initial & Last Name & Degree

Hanning Ying, MS

Phone

0086-0571-86006276

henry_yinghn@163.com

12. IPD Sharing Statement

Plan to Share IPD

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The Treatment of Bioartificial Liver With hiHep Cells After Extensive Hepatectomy

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