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

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

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1.   Scope

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.