ProChon Biotech, Ltd. (ProChon), is planning to complete the clinical trial entitled “Phase II Study to Investigate the Efficacy and Safety of BioCart II in the Treatment of Symptomatic Cartilage Defects of the Femoral Condyle in Comparison With Microfracture” for the BioCart Autologous Cartilage Regeneration System by May 2015. The study will compare the efficacy and safety of BioCart II treatment compared to microfracture which is the classical method of treatment. The study is being conducted in US and Israel.
The phase II randomized, open label, parallel assignment, safety/efficacy study is currently recruiting approximately 40 participants. The study director is Avner Yayon, PhD MD ProChon Biotech Ltd.
BioCart Autologous Cartilage Regeneration System is a tissue regeneration implant designed for the treatment of joint cartilage defects and injuries. The implant is used in the injury site to support restoration and regeneration of the cartilage tissue. The implant has autologous chondrocytes expanded and seeded onto a 3D scaffold. 3D scaffold is an interconnected open pore structure made of fibrin based component along with hyaluronic acid. It enables random distribution of chondrocytes. The implant fills the defect site stimulating the formation of hyaline cartilage.