Over 6 million Italians, half over 50, suffer from osteoarthritis, chronic progressive degenerative disease affecting the joints, particularly the hip and knee. A difficult condition that causes pain, difficulty in movement, loss of autonomy with limitations in personal and social life. Against osteoarthritis, a multicentre study of the Campus Bio Medico in Rome works, as demonstrated by the pre-clinical results, a new ‘made in Italy’ medical device, born from the partnership between Ibsa Farmaceutici and some Italian clinical and research centers of excellence, capable of optimally mimic the characteristics and behavior of healthy endogenous synovial fluid.
“Despite being one of the pathologies with the highest social impact and with a growing incidence trend, osteoarthritis is still a neglected disease today – he comments Biagio Zampogna, specialist in Orthopedics and Traumatology at the Campus Bio-Medico University Hospital of Rome – Cartilages are prone to wear and thin as we age for tissue aging, but this process can also arise at a young age due to loads and stress on the joints that are not foreseen by nature, for example: overweight and obesity, sedentary lifestyle or, on the contrary, excessive sport and trauma. These conditions give way to an unstoppable degenerative process which, if not identified and treated early with the most appropriate therapy, over time leads to an acceleration of the arthritic processes “.
Management of osteoarthritis is not always simple because it requires a flexible and gradual clinical-therapeutic approach starting from pharmacological, physiotherapeutic and infiltrative treatments up to surgical procedures in the most serious cases. For those who do not respond to the first steps of treatment, the approach recommended by the main guidelines in the osteoarticular field is viscosupplementation with intra-articular infiltrations of hyaluronic acid, which has long been used and recognized as a conservative solution for osteoarthritis, with benefits on joint pain and function.
When the arthrosic process begins, in fact, the quantity of hyaluronic acid is reduced, compromising the normal characteristics of the synovial fluid, which performs a lubricating and protective function. Viscosupplementation is therefore needed to restore its viscoelastic properties and relieve the symptoms of degenerative disease. “Thanks to the collaboration between our research and development department and several Italian clinical and research centers, including the Biomedical Campus of Rome and the University of Campania Luigi Vanvitelli, we have developed a new medical device capable of mimicking the characteristics and behavior of healthy endogenous synovial fluid in an optimal way ”- he explains Andrea Giori, R & d director of Ibsa Farmaceutici – Through our patented technology, the ‘Nahyco technology’, we have been able to obtain an innovative formulation characterized by the highest concentration of highly purified hyaluronic acid and by the use, for the first time in an injectable device, of sodium chondroitin, also it ultrapure. Both ingredients are produced via bio-fermentation, that is, they are free of components of animal origin, this has made it possible to obtain greater performance combined with greater safety, for the benefit of patients “.
“Our research group has perfected for the first time the biofermentative production process of sodium chondroitin, a component physiologically present in the body, albeit in smaller quantities than chondroitin sulphate, but with characteristics and a safety profile superior to extractive product used up to now, and therefore more suitable for use in medical devices – intervenes Chiara Schiraldi, full professor of Biochemistry, Department of Experimental Medicine University of Campania ‘Luigi Vanvitelli – It is an innovative, patented biotechnological process, together with the uses in the biomedical field of the biotechnological chondroitin itself. Our studies have allowed us to identify a new functional ingredient in chondroitin that has allowed us to overcome the limits of the traditionally adopted animal extractive origin, thus obtaining an innovative, more performing component from the point of view of rheology and safety “.
The surprising pre-clinical results were then reflected in the multicentre study, in which the Rome Biomedical Campus led, which evaluated the safety and efficacy of intra-articular infiltration with the association of hyaluronic acid and chondroitin. of biofermentative origin on patients suffering from osteoarthritis of the hip, one of the most difficult joints to treat and manage. The results showed that, in addition to an excellent safety and tolerability profile, the medical device exerts a rapid and significant improvement in pain and joint function.
“The results of the clinical study showed that the effectiveness of the new formulation is long-lasting, up to six months from the first, single, infiltration – adds Zampogna – In the clinical study the single administration use of the new formulation was studied for test its safety, performance and durability. In clinical practice, however, the therapeutic scheme is designed by the specialist according to the clinical picture and the specific needs of each patient “.