TiGenix submits cartilage MAA
Leuven – The Belgian regenerative medicine specialist TiGenix has submitted a Marketing Authorisation Application (MAA) to the EMEA with the aim of gaining central approval for ChondroCelect, the company’s product candidate for the treatment of cartilage defects in the knee. The data included in the dossier is based on a clinical trial comparing ChondroCelect to microfracture, the current gold standard. Though the clinical outcome of both measures was comparable, TiGenix believes that the formed regenerated tissue has superior features. ChondroCelect is the first product for knee cartilage repair that will follow the EMEA’s new centralised marketing authorisation procedure as a cell therapy medicinal product.