Clinical trial NCT05035108: 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
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Hepatoma Resectable
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
Collaborators: name: Hexaell Biotech Co., Ltd.
First posted: 2021-09-05
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The incidence of adverse events (safety and tolerability).
timeFrame: 3 months after therapy
Secondary outcomes:
measure: Patient's recovery of liver function
timeFrame: 1day,3day,7day,1month,3 months after therapy
measure: Rate of liver proliferation
timeFrame: 7day,1month,3 months after therapy
measure: Incidence of liver failure
timeFrame: 1day,3day,7day,1month,3 months after therapy
measure: Complication rate
timeFrame: 1day,3day,7day,1month,3 months after therapy
measure: Immunoinflammatory index
timeFrame: 1day,3day,7day,1month,3 months after therapy
measure: Renal function
timeFrame: 1day,3day,7day,1month,3 months after therapy
measure: Electrolyte level
timeFrame: 1day,3day,7day,1month,3 months after therapy
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital
state: Zhejiang
Study officials:
affiliation: Sir Run Run Shaw Hospital
name: Yifan Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: