The Treatment of Bioartificial Liver With hiHep Cells After Extensive Hepatectomy

Официальное название

A Clinical Study of hiHep Cells for Bioartificial Liver After Extensive Hepatectomy

Обзор

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.

Подробное описание

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.

Вмешательства

• Биопрепарат hiHep bioartificial liver therapy
  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)

Первичные конечные точки

• The incidence of adverse events (safety and tolerability). [Срок оценки: 3 months after therapy]

Вторичные конечные точки (7)

• Patient's recovery of liver function [Срок оценки: 1day,3day,7day,1month,3 months after therapy]
• Rate of liver proliferation [Срок оценки: 7day,1month,3 months after therapy]
• Incidence of liver failure [Срок оценки: 1day,3day,7day,1month,3 months after therapy]
• Complication rate [Срок оценки: 1day,3day,7day,1month,3 months after therapy]
• Immunoinflammatory index [Срок оценки: 1day,3day,7day,1month,3 months after therapy]
• Renal function [Срок оценки: 1day,3day,7day,1month,3 months after therapy]
• Electrolyte level [Срок оценки: 1day,3day,7day,1month,3 months after therapy]

Критерии участия

Критерии включения

• 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%;

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw H — Ханчжоу

Идентификаторы

NCT: NCT05035108 · SRRSH20201110-8

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗