NCT07276568

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

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

• Status: Enrolling By Invitation
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Zhi-Jun Zhu · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Small-for-size Syndrome

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2025-12-17
• Primary completion: 2028-12-01
• Completion: 2029-12-01
• First posted: 2025-12-11
• Last updated: 2026-04-15

Locations

1 site across 1 country: China