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NOT YET RECRUITING
NCT07276568
EARLY_PHASE1

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

Sponsor: 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.

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

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2025-12-01

Completion Date

2029-12-31

Last Updated

2025-12-11

Healthy Volunteers

No

Interventions

DRUG

Hepatocyte-like cell administration via rectus sheath intramuscular injection

On the basis of standard medical therapy, patients will receive an intramuscular injection of CiPS-derived hepatocyte cells into the rectus sheath. The method, dose, timing, and treatment course of rectus sheath injection of CiPS-derived hepatocyte cells (adjusted by body weight for adults/adolescents) are set as follows: ① Cell quantity: A dose-escalation design (ranging from 1.6 × 10⁷/kg to 1.7 × 10⁸/kg) will be adopted. Treatment will initiate at the lower dose (1.6 × 10⁷/kg). Upon successful safety review, the dose will be gradually escalated up to a maximum of 1.7 × 10⁸/kg.