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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCL001 cell injection (homologous allogeneic hepatocytes) | Experimental | low/middle/high dose group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HCL001 cell (homologous allogeneic hepatocytes) injection | Drug | 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 least one week. |
| Measure | Description | Time Frame |
|---|---|---|
| Types and incidence of treatment-related adverse events. | Recording the types and incidence of treatment-related adverse events. | The entire process of treatment (up to 48 weeks). |
| Dose-Limiting Toxicity (DLT) | 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). | 28 days after the completion of treatment. |
| Maximum Tolerated Dose (MTD) | 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). | 28 days after the completion of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Child-Pugh grading. | Child-Pugh scoring is a scoring system used to assess the liver function and prognosis of patients with cirrhosis, typically used to evaluate the severity of liver disease in patients. Child-Pugh scoring is based on several indicators of the patient, including the following five indicators: Total bilirubin levels Albumin levels Coagulation function (prothrombin time or PT) Degree of Ascites Presence of hepatic encephalopathy Child-Pugh scoring assesses the above five indicators and classifies patients into three grades A, B, or C, representing mild, moderate, and severe conditions respectively. A higher score indicates more severe liver dysfunction. Child-Pugh scoring is primarily used to evaluate the liver function and prognosis of patients with liver disease, assisting physicians in developing treatment plans and assessing the severity of the patients' conditions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiang Xia, Professor | Contact | 13661889035 | xiaqiang@medmail.com | |
| Han-yong Sun, Doctor | Contact | 15921197267 | hanyongsun@163.com |
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|
| 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 | Objective laboratory tests/examinations (ALT, AST, TBIL, DBIL, TP, ALB, GLB, Hb, white blood cell count, and platelet count.) | 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 | Ultrasound examination | At week 12, 24, and 48 after the initial administration of medication. |
| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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