ASTM F3209-24A - Standard Guide for Autologous Platelet-Rich Plasma, Platelet Gels, and Whole Blood Gels for Use in Tissue Engineering and Cell Therapy

1.1 This guide defines terminology and identifies key fundamental properties of autologous platelet-rich plasma (PRP), platelet gels, and whole blood gels (WBGs) intended to be used for tissue engineered medical products (TEMPS) or for cell therapy applications. This guide provides a common nomenclature and basis for describing notable properties and processing parameters for PRP, platelet gels, and WBGs that may have utility for manufacturers, researchers, and clinicians. Further discussion is also provided on certain aspects of product processing techniques, characterization, and quality assurance and how those considerations may impact key properties. The product characteristics outlined in this guide were selected based on a review of contemporary scientific and clinical literature but do not necessarily represent a comprehensive inventory; other significant unidentified properties may exist or be revealed by future scientific evaluation. This guide provides general recommendations for how to identify and cite relevant characteristics of PRP, platelet gels, or WBGs based on broad utility; however, users of this standard should consult referenced documents for further information on the relative importance or significance of any particular characteristic in a particular context.

1.2 The scope of this guide is confined to aspects of PRP, platelet gels, and WBGs derived and processed from autologous human peripheral blood. PRP, as defined within the scope of this standard, may include leukocytes.

1.3 The scope of this document is limited to guidance for PRP, platelet gels, and WBGs that are intended to be used for TEMPS or for cell therapy applications. Processing of PRP, platelet gels, and WBGs or other platelet concentrates or blood components for direct intravenous transfusion is outside the scope of this guide. Apheresis platelets and other platelet concentrates utilized in transfusion medicine are outside the scope of this document. Production of PRP or platelet gels for diagnostic or research applications unrelated to PRP intended for TEMPS or cell therapy is also outside the scope of this guide. Fibrin gels devoid of platelets are also excluded from discussion within this document.

1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.