Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hexaell Biotech Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| extensive hepatectomy patient | Experimental | hiHep bioartificial liver therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiujun Cai, MD | Contact | 0086-0571-86006605 | caixiujunzju@yahoo.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yifan Wang, MD | Sir Run Run Shaw Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital | Recruiting | Hangzhou | Zhejiang | 310000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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 |