ASTM F3209-16
(Guide)Standard Guide for Autologous Platelet-Rich Plasma for Use in Tissue Engineering and Cell Therapy
Standard Guide for Autologous Platelet-Rich Plasma for Use in Tissue Engineering and Cell Therapy
SIGNIFICANCE AND USE
4.1 Autologous PRP and platelet gels are utilized in a wide range of orthopedic, sports medicine, regenerative medicine, and surgical applications (3-5). PRP and platelet gels 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, 6). 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 (7). 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, 8-13). This guide outlines basic guidelines to describe key properties of unique PRP and platelet gel formulations in a standardized fashion. Reliable, standardized descriptions can provide valuable context to PRP end users, such as clinicians seeking a PRP or platelet gel with certain biological attributes or scientific investigators seeking to duplicate a published formulation or to correlate a given PRP or platelet gel feature to other biological properties or outcomes.
SCOPE
1.1 This guide defines terminology and identifies key fundamental properties of autologous platelet-rich plasma (PRP) and PRP-derived platelet gels 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 and platelet gels that may have utility for manufacturers, researchers, and clinicians. Further discussion is also provided on certain aspects of PRP processing techniques, characterization, and quality assurance and how those considerations may impact key properties. The PRP characteristics outlined in this guide were selected based n 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, based on broad utility; however, users of this standard should consult referenced documents for further information on the relative import or significance of any particular PRP characteristic in a particular context.
1.2 The scope of this guide is confined to aspects of PRP and platelet gels derived and processed from autologous human peripheral blood. Platelet-rich plasma, as defined within the scope of this standard, may include leukocytes.
1.3 The scope of this document is limited to guidance for PRP and platelet gels that are intended to be used for TEMPS or for cell therapy applications. Processing of PRP, other platelet concentrates or other 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 standar...
General Information
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Standards Content (Sample)
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.
Designation: F3209 − 16
Standard Guide for
Autologous Platelet-Rich Plasma for Use in Tissue
1
Engineering and Cell Therapy
This standard is issued under the fixed designation F3209; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope therapy is also outside the scope of this guide. Fibrin gels
devoid of platelets are also excluded from discussion within
1.1 This guide defines terminology and identifies key fun-
this document.
damental properties of autologous platelet-rich plasma (PRP)
1.4 This standard does not purport to address all of the
and PRP-derived platelet gels intended to be used for tissue
safety concerns, if any, associated with its use. It is the
engineered medical products (TEMPS) or for cell therapy
responsibility of the user of this standard to establish appro-
applications. This guide provides a common nomenclature and
priate safety and health practices and determine the applica-
basis for describing notable properties and processing param-
bility of regulatory limitations prior to use.
eters for PRP and platelet gels that may have utility for
manufacturers, researchers, and clinicians. Further discussion
2. Referenced Documents
is also provided on certain aspects of PRP processing
2
techniques, characterization, and quality assurance and how 2.1 ASTM Standards:
F1251 Terminology Relating to Polymeric Biomaterials in
those considerations may impact key properties. The PRP
3
characteristics outlined in this guide were selected based n a Medical and Surgical Devices (Withdrawn 2012)
F2149 Test Method for Automated Analyses of Cells—the
review of contemporary scientific and clinical literature but do
not necessarily represent a comprehensive inventory; other Electrical Sensing Zone Method of Enumerating and
Sizing Single Cell Suspensions
significant unidentified properties may exist or be revealed by
F2312 Terminology Relating to Tissue Engineered Medical
future scientific evaluation. This guide provides general rec-
ommendations for how to identify and cite relevant character- Products
4
istics of PRP, based on broad utility; however, users of this
2.2 ISO Standards:
standard should consult referenced documents for further
ISO 5725–1 Accuracy (trueness and precision) of Measure-
information on the relative import or significance of any
ment Methods and Results—Part 1: General Principles
particular PRP characteristic in a particular context.
and Definitions—Technical Corrigendum 1
ISO 5725–2:1994 Accuracy (trueness and precision) of
1.2 The scope of this guide is confined to aspects of PRP
Measurement Methods and Results—Part 2: Basic
andplateletgelsderivedandprocessedfromautologoushuman
Method for the Determination of Repeatability and Re-
peripheral blood. Platelet-rich plasma, as defined within the
producibility of a Standard Measurement Method—
scope of this standard, may include leukocytes.
Technical Corrigendum 1
1.3 The scope of this document is limited to guidance for
PRP and platelet gels that are intended to be used for TEMPS 3. Terminology
or for cell therapy applications. Processing of PRP, other
3.1 Definitions:
platelet concentrates or other blood components for direct
3.1.1 atuologous, adj—cells, tissues, and organs in which
intravenous transfusion is outside the scope of this guide.
the donor and recipient is the same individual. Synonyms:
Apheresis platelets and other platelet concentrates utilized in
autogenous, autograft, or autotransfusion, a self-to-self graft.
transfusion medicine are outside the scope of this document.
F2312
Production of PRP or platelet gels for diagnostic or research
applications unrelated to PRP intended for TEMPS or cell
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and the ASTM website.
3
Surgical Materials and Devices and is the direct responsibility of Subcommittee The last approved version of this historical standard is referenced on
F04.43 on Cells and Tissue Engineered Constructs for TEMPs. www.astm.org.
4
Current edition approved Oct. 1, 2016. Published December 2016. DOI: Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F3209-16. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM In
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