FDA approach to MAS cell therapy

WASHINGTON - FDA indicated last week that it has established a regulatory framework for therapies, such as Genzyme Tissue Repair's Carticel, that use manipulated autologous cells for structural repair or reconstruction.

Carticel, which involves culturing a patient's cartilage and implanting it in the knee to promote recovery from an injury, will be the first MAS cell therapy regulated under the policies. ...