A Clinical Study of hiHep Cells for Bioartificial Liver After Extensive Hepatectomy
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The incidence of adverse events (safety and tolerability).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%;
排除标准
- •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.
研究组 & 干预措施
extensive hepatectomy patient
hiHep bioartificial liver therapy
干预措施: hiHep bioartificial liver therapy (Biological)
结局指标
主要结局
The incidence of adverse events (safety and tolerability).
时间窗: 3 months after therapy
Record adverse events (AE), serious adverse events (SAE), and AEs (TEAE) that occurred during treatment.
次要结局
- Incidence of liver failure(1day,3day,7day,1month,3 months after therapy)
- Rate of liver proliferation(7day,1month,3 months after therapy)
- Immunoinflammatory index(1day,3day,7day,1month,3 months after therapy)
- Electrolyte level(1day,3day,7day,1month,3 months after therapy)
- Patient's recovery of liver function(1day,3day,7day,1month,3 months after therapy)
- Complication rate(1day,3day,7day,1month,3 months after therapy)
- Renal function(1day,3day,7day,1month,3 months after therapy)
研究者
Xiujun Cai
The director of Sir Run Run Shaw Hospital
Sir Run Run Shaw Hospital