Hyaluronic acid and sodium cromoglycate (J.O.I.N.T project): Analysis of Inflammatory Cytokine Production Using a Co-Culture Model of Chondrocytes and Mast Cells

Osteoarthritis (OA) has long been considered a “non-inflammatory” form of arthritis. However, recent immunohistochemical studies have demonstrated the presence of inflammatory infiltrates and, notably, mast cells within the synovial membrane of osteoarthritic joints. Given the crucial role of these elements in the pathogenesis and progression of OA, there is growing interest in synovial mast cells and, consequently, in drugs capable of inhibiting them, such as sodium cromoglycate. Intra-articular injections of hyaluronic acid are widely used in OA management, providing symptom relief and improving patients’ quality of life. Nevertheless, their effect is time-limited and highly variable, prompting the development of combined formulations to enhance efficacy. Following promising in vitro results with cromones for mast cell inhibition, we patented a novel compound combining the beneficial properties of hyaluronic acid and sodium cromoglycate. Mast cells play a key role in OA pathogenesis and in the production of cytokines involved in pain transmission (e.g., NGF). Therefore, this formulation represents a treatment capable of addressing both OA symptoms and underlying pathogenic mechanisms. These features highlight its potential as an innovative therapy with significant clinical applications, considering the global prevalence of OA as a true pandemic. Moreover, the development of a solution combining hyaluronic acid and sodium cromoglycate constitutes an absolute novelty in the pharmaceutical landscape. ​