A Clinical Trial Evaluating the Safety, Tolerability, and Preliminary Efficacy of HCL001 Cell Injection (Homologous Allogeneic Hepatocytes) in Patients With Decompensated Cirrhosis

Официальное название

Clinical Trial Evaluating the Efficacy of Homologous Allogeneic Hepatocytes in Patients With Decompensated Cirrhosis

Обзор

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.

Вмешательства

• Препарат HCL001 cell (homologous allogeneic hepatocytes) injection
  The patient will undergo a DSA procedure in the hospital's operating room before infusion. A catheter will be inserted into the femoral artery and guided to the hepatic artery. Upon confirmation through imaging, HCL001 cell injection will be slowly infused through the catheter. During the infusion, the cells should be continuously agitated to prevent clumping. The infusion can be administered as a single dose or multiple doses, and after infusion, the patient will be closely monitored for at lea

Первичные конечные точки

• Types and incidence of treatment-related adverse events. [Срок оценки: The entire process of treatment (up to 48 weeks).]
• Dose-Limiting Toxicity (DLT) [Срок оценки: 28 days after the completion of treatment.]
• Maximum Tolerated Dose (MTD) [Срок оценки: 28 days after the completion of treatment.]

Вторичные конечные точки (3)

• Child-Pugh grading. [Срок оценки: On the 7th day, 28th day, 42nd day (only for multiple-dose group), 56th day (only for multiple-dose]
• Number of participants with abnormal laboratory tests results [Срок оценки: 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 [Срок оценки: At week 12, 24, and 48 after the initial administration of medication.]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06306781 · HI-IM-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗