Development of classification and criteria of quality and safety of autologous platelet concentrates for regenerative injection therapy in traumatology and orthopedics

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Regenerative injection therapy (synonyms – orthobiology, prolotherapy) is considered the newest direction of orthopedics, which studies the use of cell technologies and new materials to ensure reparative or physiological regeneration in various diseases and injuries of the musculoskeletal system. The substantiation of the therapeutic effectiveness of autologous platelet concentrates, depending on the manufacturing features and characteristics of these biotechnological products, remains an urgent problem. The purpose of the study was to develop the classification and quality and safety criteria of autologous platelet concentrates for regenerative injection therapy in traumatology and orthopedics. Material and methods. A comparative study of 778 autologous platelet concentrates of various types, made from the blood of patients with osteoarthritis and aseptic necrosis of the hip and knee joints due to damage to ligaments and tendons, osteochondrosis of the spine, was conducted. In biotechnological products, the content of platelets and leukocytes was determined, the ratio of platelets and leukocytes among themselves and relative to their content in peripheral blood was calculated, respectively. During the production of autologous platelet concentrates, the visual characteristics of cell sediment and plasma were evaluated. Products of platelet cryolysates were subject to microbiological testing. Results. The classification of autologous platelet concentrates according to the concentration of platelets and leukocytes was developed, as well as the quality and comprehensive safety criteria of cellular forms of autologous platelet concentrates were determined: platelet index of autologous platelet concentrate, leukocyte index of autologous platelet concentrate, leukocyte-platelet index of autologous platelet concentrate. Visual characteristics of platelet concentrates were established: “ideal”, “classic”, “erythrocyte”, “low cell” and “alimentary” phenotype. Based on the results of a microbiological study, the safety of platelet concentrates for intra-articular administration to orthopedic and trauma patients was established. Conclusions. The developed classification of biotechnological products from human peripheral blood, as well as their quantitative and qualitative criteria, is the basis for the development of differentiated and personalized approaches to their use in diseases and injuries of the musculoskeletal system.