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ENROLLING BY INVITATION
NCT07276568
EARLY_PHASE1

Safety, Tolerability, and Preliminary Efficacy of Hepatocyte-like Cell Injection for the Prevention and Treatment of Small-for-Size Syndrome

Sponsor: Zhi-Jun Zhu

View on ClinicalTrials.gov

Summary

To evaluate the safety, tolerability, and preliminary efficacy of rectus sheath injection of hepatocyte-like cells in the treatment and prevention of small-for-size syndrome, with the ultimate goal of improving patient survival.

Official title: A Clinical Study on the Safety, Tolerability, and Preliminary Efficacy of Hepatocyte-like Cell Injection for the Prevention and Treatment of Small-for-Size Syndrome

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2025-12-17

Completion Date

2029-12-01

Last Updated

2026-04-15

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. Cell quantity: The prespecified therapeutic dose is 1.2×10⁸/kg. To ensure safety, the first patient receives 50% of that dose (0.6×10⁸/kg). After safety confirmation, subsequent patients receive the standard 1.2×10⁸/kg (adjusted based on individual rectus sheath capacity, with actual dose recorded).

Locations (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, Province, China