NCT06741098

A Study of NCR100 Injection for the Treatment of Knee Osteoarthritis（ KOA）

A Study to Evaluate the Safety, Tolerability and Efficacy of NCR100 Injection for the Treatment of Knee Osteoarthritis（ KOA）

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 162 (estimated)
• Sponsor: Nuwacell Biotechnologies Co., Ltd. · Industry
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This clinical study is to investigate the safety and efficacy of NCR100 injection in subjects with knee osteoarthritis (KOA). It contains two parts dose-escalating, and blind random 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.In China, the estimated number of patients diagnosed with KOA reached 37.35millon. The aim of this sudy is to evaluate the safety tolerability and efficacy of human pluripotent stem cell derived mesenchymal stromal cells (NCR100) injection in the treatment of subjects with knee osteoarthritis.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
BIOLOGICAL	NCR100	Subjects will receive multiple intra-articular NCR100 injections.
OTHER	0.9% Normal saline	Subjects will receive multiple intra-articular 0.9% Normal saline injections.

Timeline

• Start date: 2025-02-20
• Primary completion: 2026-11-30
• Completion: 2028-11-15
• First posted: 2024-12-18
• Last updated: 2024-12-18