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International Journal of Clinical Rheumatology Opinion Article Technology rationale for the development of CellularMatrix® A-CP-HA Kit, certified medical device allowing the combination of platelet rich plasma and hyaluronic acid for the treatment of osteoarthritis The composition of synovial fluid of patients suffering from osteoarthritis (OA) is altered with reduced concentration and molecular weight of Hyaluronic Acid (HA) and augmentation of catabolic enzymes and inflammatory markers. Intra-Articular (IA) injections of exogenous HA aim to restore the rheological properties of the synovial fluid in the osteoarthritic joints. However, clinical studies have shown that the benefit of HA injections lasts only for around 6 months and that many patients don't respond well to repeated course of HA treatment. On the other side, platelet rich plasma (PRP) IA injections have been shown to reduce pain and improve joint mobility, probably by modulating the expression of catabolic enzymes and inflammatory markers. As injections of HA and PRP use different pathway to alleviate symptoms in OA patients, the concept of combining these two treatments has emerged recently. In vitro evaluations and preliminary studies have demonstrated the therapeutic potential of this new therapeutic approach for OA treatment. To meet the needs of medical practitioners that want to treat their patients with this new treatment option, an innovative medical device, the CellularMatrix A-CP-HA Kit, has been specifically designed. This device is the first certified medical device that allows the combination of PRP and HA in manner compliant with medical devices regulation and good clinical practice.

Regenerative medicine, based on the use of autologous tissues and embryonic, stem or differentiated cells, is gaining growing interest. However, their preparation, in a manner compliant with good practices and health regulations, is a technical challenge. The aim of this manuscript is to present the design of reliable CE marked medical devices for the preparation of standardized platelet-rich plasma (PRP) and other autologous biologics intended for therapeutic uses. There are numerous PRP isolation processes. Depending on the methodology used, PRP composition varies greatly in terms of platelet concentration, platelet quality, and level of contamination with red and white blood cells. This variability in PRP composition might affect the clinical outcomes. The devices presented here are based on a specific technology, patented all over the world, that allows the precise separation of blood components as a function of their density using thixotropic separator gels in closed systems. This allows the preparation, in an automated manner, of leukocyte poor PRP with a standardized composition. Production of different forms of PRP is a clinical asset to suit various therapeutic needs. Therefore, we are offering solutions to prepare PRP either in liquid or gel form, and PRP combined with hyaluronic acid. These biologics have been successfully used in many different therapeutic domains, resulting in more than 150 published clinical studies. We also developed the CuteCell technology platform for cell culture expansion for further autologous cell therapies. This technology enables the safe and rapid in vitro expansion of cells intended for therapeutic use in good manufacturing practices (GMP) and autologous conditions, using blood-derived products as culture media supplementation. We summarize in this article our 20 years’ experience of research and development for the design of PRP devices and, more recently, for PRP combined with hyaluronic acid.