Standard Guide for Autologous Platelet-Rich Plasma, Platelet Gels, and Whole Blood Gels for Use in Tissue Engineering and Cell Therapy
Importancia y uso:
4.1 Autologous PRP, platelet gels, and WBGs are utilized in a wide range of orthopedic, sports medicine, regenerative medicine, wound care, and surgical applications (3-8). PRP, platelet gels, and WBGs are layered, sprayed, injected, molded, or packed, alone or in combination with graft material or TEMPs, into a variety of anatomical sites, tissues, and voids (3, 9). These platelet concentrates can provide an assortment of bioactive molecules, cells, and physical properties that are potentially attractive for promoting healing and other cell therapy applications (10). Unfortunately, the term “platelet-rich plasma” or “PRP,” which is ubiquitous in early and contemporary medical literature related to a variety of platelet concentrates, only unambiguously denotes one critical parameter of a platelet suspension—increased platelet concentration. Without further context, this common description of PRP offers no information about other important physical and cellular aspects of platelet concentrations. As scientific and clinical understanding of PRP and other cellular therapies increases, standardization of nomenclature and terminology is critical for defining key properties, standardizing processing parameters and techniques, and developing repeatable assays for quality assurance and scientific evaluation (5, 11-16). This guide outlines basic guidelines to describe key properties of unique PRP, platelet gel, and WBG formulations in a standardized fashion. Reliable, standardized descriptions can provide valuable context to PRP end users, such as clinicians seeking a PRP, platelet gel, or WBG with certain biological attributes or scientific investigators seeking to duplicate a published formulation or to correlate a given PRP, platelet gel, or WBG feature to other biological properties or outcomes.
4.2 The PRP, platelet gel, and WBGs can be made by the healthcare provider utilizing their own suppliers, or they may use regulatory cleared systems to prepare a consistent PRP, platelet gel, or WBG output. If a kit is used, then both the kit and the output (PRP, WBG) are typically reviewed by regulatory authorities. Often use of a regulatory authority cleared system is required for reimbursement submission.
Subcomité:
F04.43
Volúmen:
13.02
Número ICS:
11.100.30 (Analysis of blood and urine)
Palabras clave:
cell and tissue engineering; cell therapy; platelet concentrate; platelet gel; platelet-rich plasma; processing of platelet-rich plasma; PRP; tissue engineered medical products; whole blood gel;
$ 1,194
Norma
F3209
Versión
24a
Estatus
Active
Clasificación
Guide
Fecha aprobación
2024-12-01
