BACKGROUND: Intra-articular hyaluronic acid (IAHA) products are often used in the treatment of adults with mild-to-moderate knee osteoarthritis (KOA). The International Symposium on Intra-Articular Treatment (ISIAT) convened a multidisciplinary technical expert panel to define characteristics for an innovative IAHA product that should answer unmet needs in the clinical management of adults with mild-to-moderate KOA. METHODS: An initial set of evidence-based statements was developed based on data extracted from articles identified through a comprehensive literature search. A Delphi panel comprising 19 experts in KOA voted in 3 rounds to rate their degree of agreement with accepted statements. RESULTS: The final set of 13 accepted statements focus on the effect of an innovative IAHA across 5 key domains of nociceptive pain, joint function, quality of life, joint structure and integrity, and adverse effects. The statements set thresholds for clinically meaningful improvements that exceed those generally achievable by currently available IAHA products. CONCLUSION: The characteristics described by these statements from the ISIAT set new standards for what should be expected from an innovative IAHA. These statements should serve as a framework for driving the development of innovative IAHA products that will surpass the actual outcomes achieved by current viscosupplements in patients with mild-to-moderate KOA.

• Keywords
• consensus, innovative, intra-articular hyaluronic acid, knee osteoarthritis,
• Publication type
• Journal Article MeSH

This review shows the steps toward material selection focalized on the design and development of medical devices based on hyaluronan (HA). The selection is based on chemical and mechanical properties, biocompatibility, sterilization, safety, and scale-up costs. These facts play a vital role in the industrialization process. Approved medical devices containing-HA are illustrated to identify key parameters. The first part of this work involves the steps toward a complete characterization of chemical and mechanical aspects, reproducibility of the processes and scale up. In a second stage, we aimed to describe the preclinical in vitro and in vivo assays and selected examples of clinical trials. Furthermore, it is important to keep in mind the regulatory affairs during the research and development (R&D) using standardization (ISO standards) to achieve the main goal, which is the functionality and safety of the final device. To keep reproducible experimental data to prepare an efficient master file for the device, based on quality and recorded manufacturing data, and a rigorous R&D process may help toward clinical translation. A strong debate is still going on because the denominated basic research in HA field does not pay attention to the purity and quality of the raw materials used during the development. So that, to achieve the next generation of devices is needed to overcome the limitations of state of art in terms of efficacy, biodegradability, and non-toxicity.

• Keywords
• FDA, chemical modification, clinical data, cross-linked, hyaluronan, hydrogel, preclinical data, risk management,
• Publication type
• Journal Article MeSH
• Review MeSH