NCT06549686

A Phase III Study of CLS2901C in Patients With Osteoarthritis of the Knee

A Phase III Study Evaluating the Efficacy and Safety of CLS2901C in Patients With Osteoarthritis of the Knee

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: CellSeed Inc. · Industry
• Sex: All
• Age: 20 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of CLS2901C human allogenic chondrocyte sheets used in the osteotomy + RMSC group compared to in the osteotomy alone group of patients with osteoarthritis of the knee (OAK).

Detailed description

The investigational human cellular based product is a cell sheet made by culturing and growing chondrocytes taken from cartilage tissue derived from patients with polydactyly. To evaluate the efficacy and safety of CLS2901C human allogenic chondrocyte sheets used in the osteotomy + RMSC group compared to in the osteotomy alone group of patients with osteoarthritis of the knee (OAK). Safety is evaluated by the rate of adverse events and malfunctions. The evaluation period for each group will be approximately 14.5 months, and after the completion of the 52-week evaluation, patients who are available for follow-up will continue to be examined and observed for 5 years after sheets transplantation.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
BIOLOGICAL	CLS2901C (human [allogeneic] chondrocyte sheets)	CLS2901C (human \[allogeneic\] chondrocyte sheets)

Timeline

• Start date: 2023-10-20
• Primary completion: 2027-07-31
• Completion: 2031-07-31
• First posted: 2024-08-12
• Last updated: 2025-11-24

Locations

6 sites across 1 country: Japan