ASTM F3223-2017 Standard Guide for Characterization and Assessment of Tissue Engineered Medical Products (TEMPs) for Knee Meniscus Surgical Repair and or Reconstruction《膝半月板修复和 或重建.pdf

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1、Designation: F3223 17Standard Guide forCharacterization and Assessment of Tissue EngineeredMedical Products (TEMPs) for Knee Meniscus SurgicalRepair and/or Reconstruction1This standard is issued under the fixed designation F3223; the number immediately following the designation indicates the year of

2、original adoption or, in the case of revision, the year 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 is intended as a resource for individuals andorg

3、anizations involved in the production, delivery, and regula-tion of tissue engineered medical products (TEMPs) and othertissues intended for use in the surgical repair, replacement,and/or reconstruction of the knee meniscus.1.2 This standard does not purport to address all of thesafety concerns, if

4、any, associated 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.1.3 This international standard was developed in accor-dance with internationally recognize

5、d principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2D570 Test Method for Wate

6、r Absorption of PlasticsF1635 Test Method forin vitro Degradation Testing of Hy-drolytically Degradable Polymer Resins and FabricatedForms for Surgical ImplantsF2150 Guide for Characterization and Testing of Biomate-rial Scaffolds Used in Tissue-Engineered Medical Prod-uctsF2210 Guide for Processing

7、 Cells, Tissues, and Organs forUse in Tissue Engineered Medical Products (Withdrawn2015)3F2211 Classification for Tissue Engineered Medical Prod-ucts (TEMPs)F2212 Guide for Characterization of Type I Collagen asStarting Material for Surgical Implants and Substrates forTissue Engineered Medical Produ

8、cts (TEMPs)F2312 Terminology Relating to Tissue Engineered MedicalProductsF2386 Guide for Preservation of Tissue Engineered MedicalProducts (TEMPs) (Withdrawn 2013)3F2739 Guide for Quantifying Cell Viability within Bioma-terial Scaffolds2.2 ISO Standards:4ISO 10993-1 Biological evaluation of medical

9、 devicesISO 13022:2012 Medical products containing viable humancellsApplication of risk management and requirementsfor processing practicesISO 18362:2016 Manufacture of cell-based health careproductsControl of microbial risks during processing2.3 Code of Federal Regulations5CFR 610.12 General Biolog

10、ical Products StandardsSterilityCFR 820 Current Good Manufacturing Practice for QualitySystem RegulationCFR 1270 Current Good Manufacturing Practice for HumanTissue Intended for TransplantationCFR 1271 Current Good Manufacturing Practice for HumanCells, Tissues, and Cellular and Tissue-Based Product

11、s3. Terminology3.1 Unless provided otherwise in 3.2, terminology shall bein conformance with Terminology F2312.3.2 Definitions of Terms Specific to This Standard:3.2.1 ECM, nextracellular matrix.1This test method is under the jurisdiction of ASTM Committee F04 on Medicaland Surgical Materials and De

12、vices and is the direct responsibility of SubcommitteeF04.44 on Assessment for TEMPs.Current edition approved March 1, 2017. Published June 2017. DOI: 10.1520/F3223-17.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual

13、 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 International Organization for Standardization (ISO), ISOCentral Secretariat, BIBC II, Chemin

14、 de Blandonnet 8, CP 401, 1214 Vernier,Geneva, Switzerland, http:/www.iso.org.5Available from U.S. Government Printing Office, Superintendent ofDocuments, 732 N. Capitol St., NW, Washington, DC 20401-0001, http:/www.access.gpo.gov.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, Wes

15、t Conshohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Tr

16、ade Organization Technical Barriers to Trade (TBT) Committee.13.2.2 osteoarthritis (OA), na disease of the entire jointinvolving the cartilage, joint lining, ligaments, and underlyingbone.3.2.3 product, nTEMPs, and other tissues or devices usedin the surgical repair, replacement, augmentation and/or

17、 recon-struction of the knee meniscus.3.2.4 surgical reconstruction, nsurgical procedure to pro-mote healing of replacement meniscus structure.3.2.5 surgical repair, nsurgical procedure to promotehealing of native meniscus structure.4. Summary of Guide4.1 It is the intent of this guide to provide a

18、compendium ofinformation that may be related to the functional characteristicsof TEMPs, and other tissues or devices used in the surgicalrepair, replacement, augmentation and/or reconstruction of theknee meniscus. TEMPs may be composed of biological prod-ucts (for example, cells, organs, tissues (bo

19、th human andxenograft), derivatives, and processed biologics), biomaterials(for example, substrates and scaffolds composed of polymers,extra-cellular matrices or collagen), and biomolecules (forexample, recombinant proteins, alginates, and hyaluronates)(see Terminology F2312). Examples of TEMPs are

20、listed inClassification F2211.4.2 The reader is referred to other documents that mayprovide specific information that can be applied in the process-ing and manufacture (Guide F2210, ISO 18362: 2016), char-acterization and testing (Guide F2150; ISO 10993-1) and thepreservation, storage, transport, re

21、covery, post-preservationprocessing, quality assurance, and process control (GuideF2386-04, ISO 13022:2012) of TEMPs. Section 2lists refer-enced standards and particularly relevant Code of FederalRegulations (CFR).4.3 The application of this guide does not guarantee clinicalsuccess of a finished pro

22、duct but will help to ensure consis-tency in the properties, testing, and characterization of a givenTEMP or device developed for the purpose of enhancingsurgical repair, replacement, augmentation and/or reconstruc-tion of the knee meniscus.4.4 This guide does not suggest that all the listed tests b

23、econducted. The decision regarding applicability or suitabilityof any particular test method remains the responsibility of thesupplier, user, or regulator of the material based on applicableregulations, characterizations, and preclinical/clinical testing.5. Significance and Use5.1 Injuries to the kn

24、ee meniscus are one of the mostcommon orthopaedic problems. Meniscus injures include acutetears (such as occur in sports injuries), chronic degenerativetears, extrusion/subluxation, and/or degenerative dysfunctionthat occurs as part of the knee aging process or as a result ofmultiple meniscus surger

25、ies. Knee arthroscopy for partialexcision of the knee meniscus (partial meniscectomy) is themost commonly performed orthopaedic procedure.5.2 Complete or near complete excision of the meniscus ina young individual is associated with an early increased risk ofknee osteoarthritis due to the loss of th

26、e meniscus chondropro-tective effects. Lateral meniscal injuries tend to be more severethan medial injuries. Meniscus repair, augmentation,transplantation, and/or reconstruction is recommended in indi-viduals to restore the chondroprotective effect of the meniscus,relieve pain, and prevent degenerat

27、ive knee osteoarthritis. Thepotential of TEMPs to enhance the outcome of the surgicalmeniscus repair and/or reconstruction has been recognized.5.3 The knee joint and temporomandibular joint (TMJ) areexamples of joints with meniscal structures.5.4 TEMPS may be used with the intent of enhancing thesur

28、gical outcome by improving the biological repair at the siteof implantation, by providing mechanical function at a defectsite, or by a combination of these mechanisms.5.5 Improving surgical outcome may include improvingfunction relative to the pre-operative condition, shortening therecovery time aft

29、er surgery, relieving pain, enabling return tonormal daily activities, encouraging tissue growth into thedefect site, restoring the mechanical function of the meniscus,delaying the progression of osteoarthritis, or any combinationthereof.6. Cells6.1 Cell TypesCell-seeded products may be used. The ce

30、llpopulation may be allogenic or autologous. Cell type should bedefined in order to provide accurate and comprehensive mate-rials and methods descriptions so that studies can be repeated,the mechanisms of action can be understood and clinicalfeasibility and regulatory aspects can be ascertained. Sug

31、gestedcell populations include: (a) meniscal fibrochondrocytes, (b)mesenchymal stem cells (MSCs)/induced pluripotent stemcells (iPSCs)/embryonic stem cells (ESCs), or (c) synovio-cytes. Cells may be allogeneic or autologous. Allogeneic cellsshould be isolated, prepared, and stored at a cell/tissue b

32、ank.These cells may have undergone substantial proliferation priorto being seeded into the TEMPs product, and the cell pheno-type should be characterized and compared to a population offreshly isolated or early passage cells. It is intended that thecells in the cell/tissue bank should have significa

33、nt similaritiesto the fresh or early passage cells, in particular for propertiesthat are critical for formation and function of the TEMPs, suchas production of types I and II collagen and sulfated gly-cosaminoglycans (sGAGs). Autologous cells may be isolatedand re-implanted during the same surgical

34、procedure, orundergo proliferation prior to re-implantation. However, likethe allogeneic cells, the autologous cells should be managed toundergo minimal changes during manipulation.6.2 Cell Performance RequirementsCell lines should beestablished, maintained, and supplied in line with existingrecomme

35、ndations (1, 2, 3, 4, 5).6. In formation of the TEMPsin vitro, the cells will be combined with biomaterials, and mustbe able to attach to the biomaterial and/or extracellular matrix(ECM) of the TEMPs. For some TEMPs, the cells should beable to proliferate and secrete a functional ECM in vitro. When6

36、The boldface numbers in parentheses refer to the list of references at the end ofthis standard.F3223 172implanted, the cells may be required to synthesize an ECM invivo, function in biologic repair, or resorb, but the implantedcells and biomaterials should not induce immune or inflamma-tory response

37、s that prevent meniscus repair. Both allogeneicand autologous cells that undergo expansion and proliferationin vitro should be characterized for their differentiation capac-ity into a fibrochondrogeneic phenotype (producing type I andII collagen and sGAGs).7. Attachment and Incorporation7.1 Attachme

38、nt in vivoThe product should provide or beadaptable to clinically applicable anchoring or fixation meth-ods to enable attachment to the extent needed to enablefunction. Fixation methods include anchoring via sutures,specifically designed meniscus fixation devices, anchors,screws, and bone blocks to

39、enable attachment to the meniscalremnant, capsule, and/or bone. The products should be capableof retaining sutures, fixation devices, or anchors in a mannerthat is appropriate for the surgical procedure. Once implantedand fixed, the product should be retained in place for the timerequired for it to

40、complete its functional requirements andmaintain or at least restore the ability of the structure towithstand physiological hoop stresses and provide chondropro-tection.8. Sterilization8.1 The product shall be provided sterile to the clinical field.Acellular products may be sterilized after manufact

41、ure by anumber of different techniques, some examples of which are:ethylene oxide, gamma irradiation, or plasma irradiation. If theproduct is cellular, the product may be maintained asepticduring manufacture using a closed culture system.9. Packaging9.1 The product shall be packaged so that it can b

42、e storedand transported to the clinical site, while remaining sterile/aseptic and functional.10. Biochemical Composition and Tests10.1 Extracellular Matrix CompositionThe native menis-cus is a fibrocartilaginous matrix composed primarily ofcollagen, proteoglycans, cells, adhesion glycoproteins (1%),

43、and elastin (1%). It is recognized that TEMPs may produceECM that differs in content and distribution relative to thenative tissue, but nonetheless the produced ECM shouldfunction similarly to the native meniscal tissue. Regardless,produced collagen, glycosaminoglycans and cells withinTEMPs should b

44、e quantified with time in vivo or in culture.The extracellular matrix of TEMPs is often a collagen-basedhydrated material also containing proteoglyans, elastin, andother proteins and glycoproteins. These components can bequantified, and usually their amounts are expressed per wetweight or dry weight

45、. Composition assessments can be rela-tively simple (for example, protein content), or can be highlyspecific (quantitation of a specific molecule). In all measure-ments of TEMP composition, comparison to native meniscustissue composition is necessary.10.2 Collagen (by types)The meniscus is primarily

46、 com-posed of collagen (22% of the wet weight), with type I, II, III,V and VI all reported in meniscal tissue. However type Icollagen is the most abundant type accounting for over 90% ofcollagen in the meniscus, with type II being the second mostabundant. Type I collagen is primarily organized into

47、circum-ferential fibers within the peripheral zone of the meniscus andhelps the meniscus resist hoop stresses. Type II collagen isprimarily found in the more highly compressed inner, whitezone. Total collagen content of the TEMPs can be determinedby papain digestion of the tissue constructs. Collage

48、n contentcan be measured using a hydroxyproline assay with trans-4-hydroxyproline standards (6, 7, 8). However, this assay doesnot distinguish between types of collagen. Immunohistochemi-cal staining can be utilized to identify the specific collagentypes, such as types I, II, III, V, and VI. The ori

49、entation andarrangement of collagen fibrils within the TEMP is alsoimportant for functional tissue. Therefore, picrosirius redstaining may be used to assess collagen alignment and orga-nization throughout the TEMPs. The reader is referred to GuideF2212 for the characterization of Type I collagen as a startingmaterial for TEMPs.10.3 Proteoglycans/GlycosaminoglycansProteoglycansare the second major component of the meniscus (0.8% of thewet weight); however, they are found primarily in the inner,white zone of the meniscus and are approximately eightfoldless common than