The use of platelets in regenerative medicine and proposal for a new classification system: guidance from the SSC of the ISTH

Abstract

Autologous and single-donor allogenic platelet preparations are increasingly being used in many areas of regenerative medicine. However, there are few properly controlled randomized clinical trials, and the preparation, content and characteristics of platelet preparations are generally poorly defined and controlled. The Platelet Physiology Subcommittee of the Scientific and Standardization Committee (SSC) of the ISTH formed a working party of experts with the aim of producing consensus recommendations for guidance on the use of platelets in regenerative medicine. Owing to a lack of investigations that provide definitive evidence for the efficacy, definition and use of different platelet preparations in regenerative medicine, there were insufficient data to develop evidence-based guidelines. Therefore, the RAND method was used, which obtains a formal consensus among experts particularly when scientific evidence is absent, scarce and/or heterogeneous. Using this approach, each expert scored as 'appropriate', 'uncertain' or 'inappropriate' a series of 45 statements about the practice of regenerative medicine with platelets, which included different sections on general aspects, platelet preparations, clinical trial design, and potential utility in different clinical scenarios. After presentation and public discussion at SSC meetings, the assessments were further refined to produce final consensus recommendations, which constitute the subject of the present report.

Platelet‐rich plasma for the treatment of diabetic foot ulcers: A meta‐analysis

“…Full description encompasses the category of platelet (and leukocyte) enrichment regarding peripheral blood, whether or not fibrinogen is present and whether PRP is activated prior to application . Moreover, it should be documented whether PRP is autologous or homologous.…”

Wound Dressing Selection Is Critical to Enhance Platelet-Rich Fibrin Activities in Wound Care

“…This PRP was the same that we used in our clinical studies and was pure PRP with moderate platelet enrichment (2.03 ± 0.78 times greater than peripheral baseline) and no leukocytes. According to the guidance from the Platelet Physiology Subcommittee of the Scientific Standardization Committee, the product was classified as PRP IIA1 [11].…”

“…Currently, multiple devices and protocols to prepare PRP and other blood derivatives, such as platelet rich fibrin (PRF), have been commercialized and standardization efforts have created a framework for product description [11]. PRF can be described as a dynamic multifunctional hydrogel to be used as an active wound dressing.…”

Autologous platelet‐rich plasma for healing chronic venous leg ulcers: Clinical efficacy and potential mechanisms

“…Along with additional larger trials, an improved understanding of the mechanisms by which platelets promote wound healing in vivo and as autologous PRP gels ex vivo, and the ability to predict therapeutic success or failure, is also now required. Furthermore, recommendations for the improvement of definitions, preparation, clinical trial design, and utility in different clinical scenarios of PRP have recently been published . These recommendations will help unify the field and identify the most appropriate combinations of platelet bioactive factors to achieve maximal regenerative activity.…”

“…Furthermore, recommendations for the improvement of definitions, preparation, clinical trial design, and utility in different clinical scenarios of PRP have recently been published. 20 These recommendations will help unify the field and identify the most appropriate combinations of platelet bioactive factors to achieve maximal regenerative activity.…”