The Treatment of Bioartificial Liver With hiHep Cells After Extensive Hepatectomy
ConditionHepatoma Resectable
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age30-80
SponsorSir Run Run Shaw Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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%;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
hiHep bioartificial liver therapy
Biological/VaccineHiHep 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: extensive hepatectomy patientExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
3 months after therapySecondary outcomes
1
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.
Time frame
1day,3day,7day,1month,3 months after therapy2
Rate of liver proliferation
Remaining liver growth rate (calculation of residual liver volume based on CT three-dimensional reconstruction).
Time frame
7day,1month,3 months after therapy3
Incidence of liver failure
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 therapy4
Complication rate
Such as pleural effusion, hydrops abdominis, hemorrhage, bile leakage.
Time frame
1day,3day,7day,1month,3 months after therapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Sir Run Run Shaw Hospital
Lead sponsor
Hexaell Biotech Co., Ltd.
Collaborator
Source ClinicalTrials.gov