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

Holiuk Ye.; Strafun S.; Lushchii O.; Ostapenko T.; Smorzhevskyi V.

doi:10.22494/cot.v12i2.167

Cell and Organ Transplantology. 2024; 12(2):76-83 (e2024122167).
DOI: 10.22494/cot.v12i2.167

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

Holiuk Ye.¹, Strafun S.¹, Lushchii O.¹, Ostapenko T.², Smorzhevskyi V.³

¹State Institute of Traumatology and Orthopedics, National Academy of Medical Sciences of Ukraine, Kyiv, Ukraine
²Ukrainian Scientific and Practical Center of Endocrine Surgery, Transplantation of Endocrine Organs and Tissues of the Ministry of Health of Ukraine, Kyiv, Ukraine
³O. O. Shalimov National Scientific Center of Surgery and Transplantology of the National Academy of Medical Sciences of Ukraine, Kyiv, Ukraine

Abstract

Regenerative injection therapy (also known as orthobiology or prolotherapy) is a burgeoning field in orthopedics that explores the use of cell technologies and new materials to promote reparative or physiological regeneration in various musculoskeletal diseases and injuries. The substantiation of the therapeutic effectiveness of autologous platelet concentrates, based on their manufacturing characteristics and features, remains an ongoing challenge.
The purpose of the study was to develop the classification, quality and safety criteria of autologous platelet concentrates for regenerative injection therapy in traumatology and orthopedics.
Materials and methods. A comparative study was conducted on 778 autologous platelet concentrates of various types, derived from the blood of patients with osteoarthritis, aseptic necrosis of the hip and knee joints due to ligament and tendon damage, and osteochondrosis of the spine. 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. A classification of autologous platelet concentrates based on platelet and leukocyte concentrations was developed, along with the determination of quality and comprehensive safety criteria for cellular forms of autologous platelet concentrates: platelet index, leukocyte index, and leukocyte-platelet index. Visual characteristics of platelet concentrates were established: “ideal”, “classic”, “erythrocytic”, “low cell” and “alimentary” phenotype. Based on the results of a microbiological study, the safety of platelet concentrates for intra-articular administration in orthopedic and trauma patients was established.
Conclusions. The developed classification of biotechnological products derived from human peripheral blood, along with their quantitative and qualitative criteria, serves as the foundation for creating differentiated and personalized approaches to their use in musculoskeletal diseases and injuries.

Keywords: regenerative injection therapy; autologous platelet concentrates; leukocyte-rich platelet-rich plasma; leukocyte-poor platelet-rich plasma; platelet cryolysate

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How to cite

Holiuk Ye, Strafun S, Lushchii O, Ostapenko T, Smorzhevskyi V. Development of classification and criteria of quality and safety of autologous platelet concentrates for regenerative injection therapy in traumatology and orthopedics. Cell Organ Transpl. 2024; 12(2):76-83 (e2024122167). doi: https://doi.org/10.22494/cot.v12i2.167

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