Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310000, China
Location status: Recruiting
Location contact
Hanning Ying, MS
CONTACT
Xiujun Cai, MD
CONTACT
NCT Number: NCT05035108
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.
Interested in participating?
Request Info30 year–80 year
All sexes
Interventional
Early Phase 1
Hangzhou, Zhejiang, 310000, China
Location status: Recruiting
Hanning Ying, MS
CONTACT
Xiujun Cai, MD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 3 months after therapy
Record adverse events (AE), serious adverse events (SAE), and AEs (TEAE) that occurred during treatment.
Time frame: 1day,3day,7day,1month,3 months after therapy
Through child-pugh liver function grading standard and changes in ALT, AST, AKP, r-GGT, TBil, DBil, ALB to evaluate liver function.
Time frame: 7day,1month,3 months after therapy
Remaining liver growth rate (calculation of residual liver volume based on CT three-dimensional reconstruction).
Time frame: 1day,3day,7day,1month,3 months after therapy
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
Such as pleural effusion, hydrops abdominis, hemorrhage, bile leakage.
Time frame: 1day,3day,7day,1month,3 months after therapy
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
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
Changes in the concentration of Na+, K+, Cl+, Ca+ in blood before and after treatment.
Contact information is provided by the study sponsor or research team.
Sir Run Run Shaw Hospital
Other
A Clinical Study of hiHep Cells for Bioartificial Liver After Extensive Hepatectomy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.