Loading clinical trials...

Safety and Tolerability of Hepatocyte-like Cell Therapy for Liver Failure and Small-for-Size Syndrome | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGEARLY_PHASE1

Safety and Tolerability of Hepatocyte-like Cell Therapy for Liver Failure and Small-for-Size Syndrome

A Clinical Study on the Safety and Tolerability of Hepatocyte-like Cells in Patients With Liver Failure and Small-for-Size Syndrome

NCT07276568•Zhi-Jun Zhu

View on ClinicalTrials.gov

Summary

To evaluate the safety, tolerability, and preliminary efficacy of intramuscular injection of hepatocyte-like cells into the rectus sheath in patients with liver failure (including acute liver failure, acute-on-chronic liver failure, and chronic liver failure) and small-for-size syndrome, with the ultimate goal of improving survival rates.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must be diagnosed with liver failure or small-for-size syndrome based on clinical presentation.
•（Acute Liver Failure (ALF) An acute onset of liver failure characterized by hepatic encephalopathy of grade II or higher within 4 weeks, in a patient without pre-existing liver disease.
•Acute-on-Chronic Liver Failure (ACLF) A complex clinical syndrome characterized by acute deterioration of liver function, triggered by precipitating events, in patients with underlying chronic liver disease (with or without cirrhosis). It manifests as single or multiple organ failure(s) and is associated with high short-term mortality (28-day mortality rate ≥ 15%).
•Chronic Liver Failure (CLF) A state of chronic hepatic decompensation occurring progressively in patients with cirrhosis. It is primarily characterized by recurrent ascites and/or hepatic encephalopathy resulting from progressively declining liver function.
•Small-for-Size Syndrome (SFSS) Diagnosis is established according to the International Liver Transplantation Society (ILTS) 2023 guidelines on SFSS.） ② Patients must agree to undergo intramuscular injection of cells into the rectus sheath.

Exclusion Criteria

•\-
•Subjects meeting any of the following criteria will be excluded from the study:
•1. Presence of severe, life-threatening extrahepatic systemic diseases.
•2. Uncontrolled active infection or hemorrhage.
•3. Pregnancy or lactation in female patients.
•4. History of severe allergic reactions or known hypersensitivity to CiPS-derived cell products or blood products.
•5. Inability to undergo phlebotomy due to peripheral vascular collapse.
•6. Inability or unwillingness to provide informed consent or comply with the study procedures.
•7. Unwillingness to receive CiPS-based therapy.

Key Dates

Start Date

December 1, 2025

Primary Completion Date

December 31, 2028

Completion Date

December 31, 2029

Last Updated

December 11, 2025

Enrollment

ESTIMATED participants

Conditions

Acute Liver FailureAcute on Chronic Liver Failure (ACLF)Chronic Liver FailureSmall-for-size Syndrome

Interventions

Hepatocyte-like cell administration via rectus sheath intramuscular injection

DRUG

Contacts

Ruzhou Cai

CONTACT

+8618722563616 18722563616@126.com

ALSS - DPMAS and Therapeutic Plasma Exchange (TPE), Its Effect on Primary Coagulation, Inflammation and the Function of Vital Organs in ALF or ACLF

NCT07329036

Acute Liver Failure

View study

RECRUITINGNA

Standard Volume vs. High Volume Plasma Exchange in Pediatric Acute Liver Failure

NCT06831643

Acute Liver Failure

View study

RECRUITING

Analysis of Methylomic Features and Prognostic Risk Prediction in Patients With Hepatitis B-related Acute-on-chronic Liver Failure

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Tolerability of Hepatocyte-like Cell Therapy for Liver Failure and Small-for-Size Syndrome

Inclusion Criteria

Exclusion Criteria

ALSS - DPMAS and Therapeutic Plasma Exchange (TPE), Its Effect on Primary Coagulation, Inflammation and the Function of Vital Organs in ALF or ACLF

Standard Volume vs. High Volume Plasma Exchange in Pediatric Acute Liver Failure

Analysis of Methylomic Features and Prognostic Risk Prediction in Patients With Hepatitis B-related Acute-on-chronic Liver Failure

Single Cell Landscape of HBV-related Acute-on-chronic Liver Failure Patients

Study About Hepatic Toxins Kinetic and Evaluation of Organ Damage in Acute on Chronic Liver Failure (ACLF) Patients

Role of N-Acetylcysteine in Non-Acetaminophen-Induced Acute Liver Failure