Not yet recruitingNCT06306781Updated Mar 12, 2024

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

An interventional study of HCL001 cell (homologous allogeneic hepatocytes) injection in Decompensated Cirrhosis, sponsored by RenJi Hospital. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-03-12.

Sponsored by RenJi Hospital · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 18
Allocation: Not applicable
Ages: 18 Years to 75 Years
Sex: All

Study summary

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.

Conditions studied

Decompensated Cirrhosis

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In context

Liver Cirrhosis

1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.

This study's planned enrollment of 18 is below the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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).

Exclusion criteria

Exclusion Criteria:

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 18 participants (estimated)

Study arms

Experimental
HCL001 cell injection (homologous allogeneic hepatocytes)
low/middle/high dose group
Drug: HCL001 cell (homologous allogeneic hepatocytes) injection

Interventions

DrugHCL001 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 least one week.

What researchers measure

Primary outcomes

Types and incidence of treatment-related adverse events.
Recording the types and incidence of treatment-related adverse events.
Time frame: 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).
Time frame: 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).
Time frame: 28 days after the completion of treatment.

Secondary outcomes

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.
Time frame: 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.)
Time frame: 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
Time frame: At week 12, 24, and 48 after the initial administration of medication.

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06306781
Lead sponsor: RenJi Hospital
Responsible party: Sponsor
First posted: Mar 12, 2024
Start date: Mar 30, 2024 (estimated)
Primary completion: Jul 30, 2026 (estimated)
Completion: Dec 30, 2026 (estimated)
Last update: Mar 12, 2024

Study contacts

Qiang Xia, Professor

Contact

xiaqiang@medmail.com

13661889035

Han-yong Sun, Doctor

Contact

hanyongsun@163.com

15921197267

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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