ASTM F3209-2016 Standard Guide for Autologous Platelet-Rich Plasma for Use in Tissue Engineering and Cell Therapy《组织工程和细胞治疗用自体富血小板血浆的标准指南》.pdf

《ASTM F3209-2016 Standard Guide for Autologous Platelet-Rich Plasma for Use in Tissue Engineering and Cell Therapy《组织工程和细胞治疗用自体富血小板血浆的标准指南》.pdf》由会员分享，可在线阅读，更多相关《ASTM F3209-2016 Standard Guide for Autologous Platelet-Rich Plasma for Use in Tissue Engineering and Cell Therapy《组织工程和细胞治疗用自体富血小板血浆的标准指南》.pdf（8页珍藏版）》请在麦多课文档分享上搜索。

1、Designation: F3209 16Standard Guide forAutologous Platelet-Rich Plasma for Use in TissueEngineering and Cell Therapy1This standard is issued under the fixed designation F3209; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the yea

2、r of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This guide defines terminology and identifies key fun-damental properties of autologous platelet-rich plasma (PRP

3、)and PRP-derived platelet gels intended to be used for tissueengineered medical products (TEMPS) or for cell therapyapplications. This guide provides a common nomenclature andbasis for describing notable properties and processing param-eters for PRP and platelet gels that may have utility formanufac

4、turers, researchers, and clinicians. Further discussionis also provided on certain aspects of PRP processingtechniques, characterization, and quality assurance and howthose considerations may impact key properties. The PRPcharacteristics outlined in this guide were selected based n areview of contem

5、porary scientific and clinical literature but donot necessarily represent a comprehensive inventory; othersignificant unidentified properties may exist or be revealed byfuture scientific evaluation. This guide provides general rec-ommendations for how to identify and cite relevant character-istics o

6、f PRP, based on broad utility; however, users of thisstandard should consult referenced documents for furtherinformation on the relative import or significance of anyparticular PRP characteristic in a particular context.1.2 The scope of this guide is confined to aspects of PRPand platelet gels deriv

7、ed and processed from autologous humanperipheral blood. Platelet-rich plasma, as defined within thescope of this standard, may include leukocytes.1.3 The scope of this document is limited to guidance forPRP and platelet gels that are intended to be used for TEMPSor for cell therapy applications. Pro

8、cessing of PRP, otherplatelet concentrates or other blood components for directintravenous transfusion is outside the scope of this guide.Apheresis platelets and other platelet concentrates utilized intransfusion medicine are outside the scope of this document.Production of PRP or platelet gels for

9、diagnostic or researchapplications unrelated to PRP intended for TEMPS or celltherapy is also outside the scope of this guide. Fibrin gelsdevoid of platelets are also excluded from discussion withinthis document.1.4 This standard does not purport to address all of thesafety concerns, if any, associa

10、ted with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2F1251 Terminology Relating to Polymeric Biomaterials inMedic

11、al and Surgical Devices (Withdrawn 2012)3F2149 Test Method for Automated Analyses of CellstheElectrical Sensing Zone Method of Enumerating andSizing Single Cell SuspensionsF2312 Terminology Relating to Tissue Engineered MedicalProducts2.2 ISO Standards:4ISO 57251 Accuracy (trueness and precision) of

12、 Measure-ment Methods and ResultsPart 1: General Principlesand DefinitionsTechnical Corrigendum 1ISO 57252:1994 Accuracy (trueness and precision) ofMeasurement Methods and ResultsPart 2: BasicMethod for the Determination of Repeatability and Re-producibility of a Standard Measurement MethodTechnical

13、 Corrigendum 13. Terminology3.1 Definitions:3.1.1 atuologous, adjcells, tissues, and organs in whichthe donor and recipient is the same individual. Synonyms:autogenous, autograft, or autotransfusion, a self-to-self graft.F23121This test method is under the jurisdiction of ASTM Committee F04 on Medic

14、aland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.43 on Cells and Tissue Engineered Constructs for TEMPs.Current edition approved Oct. 1, 2016. Published December 2016. DOI:10.1520/F3209-16.2For referenced ASTM standards, visit the ASTM website, www.astm.org, o

15、rcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3The last approved version of this historical standard is referenced onwww.astm.org.4Available from American National Standards Inst

16、itute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized principles on standa

17、rdization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organiziation Technical Barriers to Trade (TBT) Committee.13.1.2 biomolecule, na biologically active peptide, protein,carbohydrate, vitamin, lipid,

18、or nucleic acid produced by andpurified from naturally occurring or recombinant organisms,tissues or cell lines or synthetic analogs of such molecules. Abiomolecule may be used as a component of a TEMP. F23123.1.3 cell therapy, nthe administration of cells (any kindand form) to repair, modify or reg

19、enerate the recipients cells,tissues, and organs or their structure and function, or both. Celltherapy technologies can be applied in tissue engineering togenerate TEMPs. F23123.1.4 device, nan instrument, apparatus, implement,machine, contrivance, implant, in vitro reagent, or other similaror relat

20、ed article intended for use in the diagnosis of disease orother conditions, or in the cure, mitigation, treatment, orprevention of disease, in man or other animals, which does notachieve its primary intended purposes through chemical actionwithin or on the body of man or other animals and which is n

21、otdependent upon being metabolized for the achievement of itsprimary intended purposes. Devices are intended to affect thestructure or any function of the body. F23123.1.4.1 DiscussionDevice Criteria: A liquid, powder, orother similar formulation intended only to serve as acomponent, part or accesso

22、ry to a device with a primary modeof action that is physical in nature. A device may be used as acomponent of a TEMP.3.1.5 donor, na living or deceased organism who is thesource of cells or tissues, or both, for research or furtherprocessing for transplantation in accordance with establishedmedical

23、criteria and procedures. F23123.1.6 gel, nthe three-dimensional network structure aris-ing from intermolecular polymer chain interactions. F23123.1.6.1 DiscussionSuch chain interactions may becovalent, ionic, hydrogen bond, or hydrophobic in nature. Seealso Terminology F1251.3.1.7 heal, vto restore

24、wounded parts or to make healthy.F23123.1.8 healing, nthe restoration of integrity to injuredtissue. F23123.1.9 processing, vtany activity performed on cells,tissues, and organs other than recovery, such as preparation andpreservation for storage and packaging. F23123.1.10 recipient, nthe individual

25、 or organism into whommaterials are grafted or implanted. F23123.1.11 recovery, nthe obtaining of cells or tissues whichmay be used for the production of TEMPs. F23123.1.12 regenerative medicine, na branch of medical sci-ence that applies the principles of regenerative biology tospecifically restore

26、 or recreate the structure and function ofhuman cells, tissues, and organs that do not adequatelyregenerate. F23123.1.13 suspension, nthe dispersion of a solid through aliquid with a particle size large enough to be detected by purelyoptical means. F23123.2 Definitions of Terms Specific to This Stan

27、dard:3.2.1 activation, vconversion of a liquid platelet-richplasma to a solid platelet-rich gel.3.2.1.1 DiscussionIn the context of platelet-rich plasma,activation can be passive or active. Passive activation is atypical consequence of removing blood from the circulatorysystem, the dynamics of which

28、 can influenced by platelet-richplasma processing. Active activation is directed action in-tended to stimulate coagulation, for example, addition of anexogenous agonist or proactive reversal of anticoagulation.3.2.2 blood cell, none of the formed elements of theblood; a leukocyte, erythrocyte or pla

29、telet. Also called bloodcorpuscle, hemacyte, hematocyte and hemocyte (1).53.2.3 cell, nthe smallest structural unit of an organism thatis capable of independent functioning, consisting of one ormore nuclei, cytoplasm, and various organelles, all surroundedby a semipermeable cell membrane (1).3.2.3.1

30、 DiscussionFor the purposes of this guide, the termcell includes all formed elements of the blood within the scopeof the term “blood cell.” Erythrocytes and platelets are anucle-ate in their mature forms, and therefore may not meet the strictdefinition for cell above. However, erythrocytes and plate

31、letsare considered or are frequently referred to as cells in platelet-rich plasma applications so they are included in the broaderscope of the term used for this guide.3.2.4 coagulation, nthe sequential process by which themultiple coagulation factors of the blood interact in thecoagulation cascade,

32、 ultimately resulting in the formation of aninsoluble fibrin clot (1) .3.2.5 erythrocyte, na mature red blood cell. Synonymouswith red blood cell, red corpuscle (2).3.2.6 leukocyte, na colorless blood cell capable of ame-boid movement; there are several different types, classified intothe two large

33、groups granular leukocytess (basophils,eosinophils, and neutrophils) and nongranular leukocytess(lymphocytes and monocytes). Also called white blood cells orcorpuscles (1).3.2.7 peripheral blood, nthe blood in the systemic circu-lation (1).3.2.8 plasma, nthe fluid portion of the blood in which thepa

34、rticulate components are suspended. Plasma is to be distin-guished from serum, which is the cell-free portion of the bloodfrom which the fibrinogen has been separated in the process ofclotting. (1)3.2.9 platelet, na disk-shaped structure, two to four mi-crometers (m) in diameter, found in the blood

35、of all mammalsand chiefly known for its role in blood coagulation; platelets,which are formed in the megakaryocyte and released from itscytoplasm in clusters, lack a nucleus and DNA but containactive enzymes and mitochondria.Also called thrombocyte (1).3.2.10 platelet concentrate, na blood-derived s

36、uspensionor gel in which the majority of erythrocytes have been removed5The boldface numbers in parentheses refer to the list of references at the end ofthis standard.F3209 162and platelets have been concentrated with respect to normalphysiological levels or with respect to the source blood prior to

37、processing.3.2.10.1 DiscussionThis definition relates to the termplatelet concentrate as generally applied within the context ofcell therapy or TEMPs applications. This definition does notnecessarily extend to applications within hematology, transfu-sion medicine, or other fields.3.2.11 platelet-ric

38、h plasma, na blood-derived plasma sus-pension from which the majority of erythrocytes have beenremoved and platelets have been concentrated with respect tonormal physiological levels or with respect to the source bloodprior to processing. Commonly abbreviated PRP.3.2.11.1 DiscussionThis definition r

39、elates to the termplatelet-rich plasma as generally applied within the context ofcell therapy or TEMPs applications. This definition does notnecessarily extend to applications within hematology, transfu-sion medicine, or other fields.3.2.12 platelet gel, na platelet-rich plasma-derived gel.Platelet

40、gels are formed from platelet-rich plasma throughpassive or directed activation of coagulation.3.2.12.1 DiscussionThis definition relates to the termplatelet gel as generally applied within the context of celltherapy or TEMPs applications. this definition does not neces-sarily extend to applications

41、 within hematology, transfusionmedicine, or other fields.3.2.13 serum, specifically blood serum, nthe clear liquidthat separates from the blood when it is allowed to clotcompletely. It is therefore blood plasma from which fibrinogenhas been removed in the process of clotting (1).4. Significance and

42、Use4.1 Autologous PRP and platelet gels are utilized in a widerange of orthopedic, sports medicine, regenerative medicine,and surgical applications (3-5). PRP and platelet gels arelayered, sprayed, injected, molded, or packed, alone or incombination with graft material or TEMPs, into a variety ofana

43、tomical sites, tissues, and voids (3, 6). These plateletconcentrates can provide an assortment of bioactive molecules,cells, and physical properties that are potentially attractive forpromoting healing and other cell therapy applications (7).Unfortunately, the term “platelet-rich plasma” or “PRP,” w

44、hichis ubiquitous in early and contemporary medical literaturerelated to a variety of platelet concentrates, only unambigu-ously denotes one critical parameter of a platelet suspensionincreased platelet concentration. Without further context, thiscommon description of PRP offers no information about

45、 otherimportant physical and cellular aspects of platelet concentra-tions.As scientific and clinical understanding of PRP and othercellular therapies increases standardization of nomenclatureand terminology is critical for defining key properties, stan-dardizing processing parameters and techniques,

46、 and develop-ing repeatable assays for quality assurance and scientificevaluation (5, 8-13). This guide outlines basic guidelines todescribe key properties of unique PRP and platelet gel formu-lations in a standardized fashion. Reliable, standardized de-scriptions can provide valuable context to PRP

47、 end users, suchas clinicians seeking a PRP or platelet gel with certainbiological attributes or scientific investigators seeking to du-plicate a published formulation or to correlate a given PRP orplatelet gel feature to other biological properties or outcomes.5. Key Properties of PRP and Platelet

48、Gels5.1 The physical and biological properties detailed in thissection have been identified in peer-reviewed scientific articlesor medical texts as factors that may potentially impact thesafety and/or effectiveness of PRP and platelet gels used forTEMPS, cell therapies, or related applications. Whil

49、e thesignificance of individual properties relative to other propertiesis beyond the scope of this guide, recommendations areincluded for attributes which are consistently identified assignificant throughout the literature. Unless otherwise noted, aparameter value or range quoted in this text is intended torepresent the average value/range for a particular PRP or geloutput; values should be expressed as mean 6 standarddeviation.Atable of key properties appears in AnnexA1, TableA1.1.5.1.1 Processing Volume:5.1.2 The whole blood input volume o