NCT07139431

A Study of [89Zr]-Oxine-NCR100 Injection for the Cellular Distribution

A Study to Evaluate the Cellular Distribution of [89Zr]-Oxine-NCR100 Injection in the Treatment of Subjects With Knee Osteoarthritis

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Nuwacell Biotechnologies Co., Ltd. · Industry
• Sex: Male
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This clinical study is to evaluate the biodistribution of \[89Zr\]-Oxine-NCR100 injection in subjects with knee osteoarthritis after local injection and the kinetic behavior characteristics of zirconium-labeled cells at the injection site and various organs or tissues. It is a single-dose, open-label study in adult KOA subjects.

Detailed description

Knee osteoarthritis(KOA) is a kind of degenerative joint disease characterized by chronic inflammation loss of articular cartilage and subchondral bone remodeling. This clinical trial aims to evaluate the biodistribution of 89Zr-labeled human pluripotent stem cell derived mesenchymal stromal cells (\[89Zr\]-Oxine-NCR100) injection in subjects with knee osteoarthritis after local injection and the kinetic behavior characteristics of the zirconium-labeled cells at the injection site and in various organs or tissues.

Conditions

• KOA

Interventions

Type	Name	Description
BIOLOGICAL	NCR100	Subjects will receive a single injection of NCR100

Timeline

• Start date: 2025-08-29
• Primary completion: 2026-03-06
• Completion: 2028-04-21
• First posted: 2025-08-24
• Last updated: 2025-08-24