NCT07052851

Performance of CCoat Intra-Articular Injections in Mild to Moderate Knee Osteoarthritis: A Prospective, Randomized, Double-Blind, Multi-center Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Lipo-Sphere · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Performance of CCoat Intra-Articular Injections in Mild to Moderate Knee Osteoarthritis: A Prospective, Randomized, Double-Blind, Multi-center Trial

Detailed description

The study aims to evaluate the performance of a single intra-articular injection of CCoat in patients with mild to moderate knee osteoarthritis over 26 weeks. Intra-articular injections are widely used for their localized efficacy and reduced systemic toxicity compared to oral treatments. Current treatments, including corticosteroids and hyaluronic acid, have limitations such as short-term effects and potential cartilage damage \[1\],\[2\],\[3\],\[4\]. Platelet-rich plasma (PRP) and mesenchymal stem cells (MSCs) offer promise but require further validation \[5\],\[6\],\[7\]. CCoat, a liposomal boundary lubricant, provides a novel approach by coating cartilage surfaces to reduce wear, offering mechanical protection without altering synovial fluid properties. CCoat is a new intra-articular (IA) injectable joint lubricant for patients suffering from mild to moderate knee osteoarthritis (OA), developed by Liposphere LTD. CCoat is a liposomal boundary lubricant that coats the cartilage surface and temporarily protects it from further damage and degradation. The performance and safety of CCoat device over 26 weeks is being evaluated in another multi-center, prospective, placebo controlled, randomized, double- blinded clinical study in 150 patients with mild to moderate OA of the knee (per study protocol # CLD0000616). As this study is ongoing, there is no currently available data related to the performance of the device. With regards to the CCoat's safety, in the interim analysis no safety concerns were raised. This clinical investigation aims to further confirm the performance of CCoat when used as intended for the treatment of mild to moderate knee osteoarthritis (OA) in a larger patient population group, in comparison to a marketed hyaluronic acid product. This study is critical to further confirm the benefit-risk profile of the CCoat device as a valid therapeutic option for knee OA treatment, which remains a significant unmet medical need.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DEVICE	CCoat, Liposphere Ltd	a single IA injection of 4 ml CCoat
DEVICE	Synvisc-One® (hylan G-F 20)	Group 2 (Active Comparator): a single IA Synvisc-One® (hylan G-F 20) of 6 mL, Genzyme Corporation

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-07-01
• Completion: 2027-01-01
• First posted: 2025-07-07
• Last updated: 2025-07-07