Clinical Trial Evaluating the Efficacy of Homologous Allogeneic Hepatocytes in Patients With Decompensated Cirrhosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 18
- 主要终点
- Dose-Limiting Toxicity (DLT)
研究概览
简要总结
This study protocol is designed to evaluate the clinical efficacy, safety, and tolerability of HCL001 cell injection in the treatment of decompensated cirrhosis. The aim is to provide stronger evidence for the clinical application of HCL001 cell injection in the treatment of decompensated cirrhosis, thereby attempting to improve patients' survival and quality of life to meet the clinical needs for treating decompensated liver cirrhosis.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •When signing the informed consent form, individuals between the ages of 18 to 75 years (inclusive, including the boundary values) are eligible, and there are no restrictions based on gender.
- •According to the "Guidelines for the Diagnosis and Treatment of Cirrhosis (2019 Edition)", a diagnosis of decompensated cirrhosis is made.
- •A Child-Pugh score of 7-12 points (including the threshold) is classified as [insert the corresponding classification as per the provided appendix].
- •An ECOG performance status score of 0-2 or a Karnofsky Performance Status (KPS) score greater than 60 is considered [insert the corresponding classification or interpretation].
- •A safe vascular access that allows for hepatic intra-arterial catheterization and angiography
- •If screening for patients with hepatitis B or C-related cirrhosis, the viral load should be ≤1000 IU/mL for HBV-DNA and ≤15 IU/mL for HCV-RNA. For patients with alcoholic cirrhosis, the abstinence period should be ≥6 months.
- •During screening, the serum ALT level should be ≤3 times the upper limit of normal (ULN).
- •Understand and adhere to the research process, voluntarily participate, and sign the informed consent form (the informed consent form is to be voluntarily signed by myself or a legally authorized representative).
排除标准
- •Allergic individuals, especially those allergic to any component of HCL001 cell injection or its excipients.
- •Individuals with concurrent liver cancer or other malignant tumors.
- •Patients who are unable or unwilling to cooperate or comply with the requirements of the research protocol.
- •International Normalized Ratio (INR) >2.5 and platelet count (PLT) less than 30 x 10^9/L.
- •Patients who have used anticoagulant or antiplatelet medications within the past week prior to screening.
- •Patients with a history of upper gastrointestinal bleeding or spontaneous peritonitis within the past four weeks prior to screening.
- •Patients who have experienced grade 3 or higher hepatic encephalopathy within the past three months prior to administering the medication.
- •Patients with severe dysfunction in vital organs such as the heart, lungs, brain, or kidneys, including: History of severe lung diseases such as severe emphysema, pulmonary embolism, or other lung conditions that significantly impact lung function. Significant history of heart disease that meets either of the following conditions: a. Decompensated heart failure (New York Heart Association [NYHA] class III-IV). b. Unstable angina. Chronic kidney disease, such as chronic nephritis, renal insufficiency, or uremia.
- •For patients with diabetes mellitus that is being treated but not effectively controlled, it typically refers to those with a glycated hemoglobin (HbA1c) level of ≥8%.
- •Patients with severe coagulation dysfunction or bleeding disorders, such as hemophilia, as well as those with severe jaundice indicated by a serum total bilirubin level of ≥171 μmol/L.
- •This includes pregnant or lactating women, as well as individuals who are unable or unwilling to follow the researcher's guidance in using the approved contraceptive measures during the study period and for 6 months after the study ends.
- •Those who have received stem cell therapy in the past, or who are currently participating in another interventional clinical trial or have been enrolled in one within the past 3 months, are excluded from screening.
- •HIV positive
- •Presence of active infection during screening
- •The researchers consider any other factors that are not suitable for trial inclusion.
研究组 & 干预措施
HCL001 cell injection (homologous allogeneic hepatocytes)
low/middle/high dose group
干预措施: HCL001 cell (homologous allogeneic hepatocytes) injection (Drug)
结局指标
主要结局
Dose-Limiting Toxicity (DLT)
时间窗: 28 days after the completion of treatment.
Recording the Dose-Limiting Toxicity (DLT) . If one or more instances of Dose-Limiting Toxicity (DLT) occur, the dose escalation according to the original plan will be stopped, and the previous dose level will be determined as the Maximum Tolerated Dose (MTD).
Types and incidence of treatment-related adverse events.
时间窗: The entire process of treatment (up to 48 weeks).
Recording the types and incidence of treatment-related adverse events.
Maximum Tolerated Dose (MTD)
时间窗: 28 days after the completion of treatment.
Recording Maximum Tolerated Dose (MTD).If one or more instances of Dose-Limiting Toxicity (DLT) occur, the dose escalation according to the original plan will be stopped, and the previous dose level will be determined as the Maximum Tolerated Dose (MTD).
次要结局
- Number of participants with abnormal laboratory tests results(On the 7th day, 28th day, 42nd day (only for multiple-dose group), 56th day (only for multiple-dose)
- Child-Pugh grading.(On the 7th day, 28th day, 42nd day (only for multiple-dose group), 56th day (only for multiple-dose)
- The percentage of participants with improved liver conditions (including changes in portal vein diam(At week 12, 24, and 48 after the initial administration of medication.)