ANNUAL FINANCIAL REPORT 2010 2010 - TiGenix

EMAFDAFibrous tissueGCPGMPGrowth factorsHistomorphometryHomeostasisHyaline cartilageHyaluronic acid; hyaluronanICHICRSImmunogeneicINDJoint surfaceJoint surface defectLigamentMAAMedicinal productMeniscusMicrofractureMusculoskeletalNotified BodiesNSAIDOAOsteochondral lesionOsteoarthritis or OAOsteocytePeriosteumEuropean Medicines Agency, regulatory authorities in Europe responsible for medicinal products, publicand animal health.Food and Drug Administration, regulatory authorities in the U.S. responsible for food and medicinalproducts.Tissue consisting mainly of fibres or fibre-containing materials, such as fibrous connective tissue.Good Clinical Practice, international regulations that must be observed to ensure high quality clinicalstudies and admissible data.Good Manufacturing Practice, industry standards according to which a production facility should beoperated in order to be allowed for production of medicinal products.A complex family of polypeptide hormones or secreted proteins that are produced by the bodyto control growth, division and maturation of cells. These factors occur naturally but some can besynthesised using molecular biology and are used in a variety of clinical indications. Examples includeepidermal growth factor, platelet-derived growth factor and fibroblast growth factor. Perturbationof growth factor production or of the response to growth factor may be important in neoplastictransformation.The quantitative measurement and characterisation of microscopical images using a computer; manualor automated digital image analysis typically involves measurements and comparisons of selectedgeometric areas, perimeters, length angle of orientation, form factors, centre of gravity coordinates, aswell as image enhancement.In medicine and biology, this term is applied to the inherent tendency in an organism towardmaintenance of physiological and psychological stability.A type of cartilage that appears translucent, bluish-white in the fresh condition and predominantlyconsists of a type II collagen network and large amounts of highly sulphated, high molecular weightproteoglycan aggregates.A mucopolysaccharide, forming a gelatinous material in the tissue spaces and acting as a lubricant andshock absorbent generally throughout the bodyThe International Conference on Harmonisation of Technical Requirements for Registration ofPharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities ofEurope, Japan and the U.S. and experts from the pharmaceutical industry in the three regions to discussscientific and technical aspects of product registration.International Cartilage Repair Society.Having the ability to provoke an immune response; having the properties of an antigen or any substancethat may trigger a particular immune reaction, such as the production of antibodies.Acronym for Investigational New Drug Application. An IND is an application filed (usually by the sponsor)with the FDA that includes a detailed description of the planned clinical investigation.The (cartilage) layer covering the ends of bones in the joint.Defect of the cartilage and often also of the underlying bone in the joint.A type of white fibrous connective tissue that connects bones or cartilage, serving to support andstrengthen joints.European Marketing Authorisation Application.Pharmaceutical product.An intra-articular structure of fibrocartilaginous tissue.Perforation of the subchondral bone plate to create a blood clot which, mixed with bone marrow stemcells, tends to form a scar-like fibro-cartilaginous repair tissue.Referring to the muscles, tendons, ligaments, cartilage, bones, joints, and spinal discs.In the European Union, a notified body is an organisation that has been accredited by a Member Stateto assess whether a product meets certain preordained standards. For this purpose, a notified Bodymay designate that a medical device conforms to the EU Medical Devices Directive, which defines thestandards for medical devices.Non-steroidal anti-inflammatory drugs.Osteoarthritis.A lesion to the joint that involves the cartilage as well as part of the underlying bone.Joint disorder associated with the degeneration of the joints including the bone and cartilage.A mature bone cell.The membrane of fibrous connective tissue which closely surrounds all bones except at the articularsurfaces, and has bone-forming potentialities.227 •