ASTM F3163-2016 Standard Guide for Classification of Cellular and or Tissue-Based Products (CTPs) for Skin Wounds《皮肤创伤用基于细胞和 或组织产品 (CTP) 分类的标准指南》.pdf

1、Designation: F3163 16Standard Guide forClassification of Cellular and/or Tissue-Based Products(CTPs) for Skin Wounds1This standard is issued under the fixed designation F3163; 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 for description of cellu-lar and/or tissue-based products (CTPs) for skin wounds.

3、CTPsare defined primarily by their composition and comprise cellsand/or the extracellular components of tissue. CTPs maycontain cells (viable or nonviable), tissues, proteins, and othermaterials for which there is a rationale for benefit beyond thatachievable with conventional wound coverings. CTPs

4、mayadditionally include synthetic components. Whether an indi-vidual CTP is capable of promoting wound healing must bedetermined by adequate evidence and is beyond the scope ofthis standard.1.2 This guide also describes a classification and nomencla-ture for CTPs based on their composition. This sys

5、tematicnomenclature is not intended to be prescriptive for productlabeling, and it describes only the most salient characteristicsof these products; the actual biological and clinical functionscan depend on characteristics not recognized in thenomenclature, and it should be understood that two produ

6、ctsthat can be described identically by the nomenclature shouldnot be presumed to be identical or have the same clinicalutility.1.3 This guide defines CTP-related terminology in thecontext of skin wounds. However, this guide does not providea correspondence between the CTP composition and its clinic

7、aluse(s). More than one product may be suitable for each clinicaluse, and one product may have more than one clinical use.1.4 This standard does not purport to address safety con-cerns with the use of CTPs. It is the responsibility of the userof this standard to establish appropriate safety and heal

8、thpractices and determine the applicability of regulatory limita-tions prior to use.2. Referenced Documents2.1 ASTM Standards:2F2027 Guide for Characterization and Testing of Raw orStarting Biomaterials for Tissue-Engineered MedicalProductsF2150 Guide for Characterization and Testing of Biomate-rial

9、 Scaffolds Used in Tissue-Engineered Medical Prod-uctsF2311 Guide for Classification of Therapeutic Skin Substi-tutesF2312 Terminology Relating to Tissue Engineered MedicalProductsF2739 Guide for Quantitating Cell Viability Within Bioma-terial Scaffolds3. Terminology3.1 Skin Tissue Definitions:3.1.1

10、 dermal, adjpertaining to the dermis (1).33.1.2 dermis, nthe layer of the skin deep to the epidermis,consisting of a dense bed of vascularized connective tissue (1).3.1.3 dermoepidermal junction (DEJ), ndistinct anatomiczone between the epidermis and dermis that facilitates adher-ence between the tw

11、o layers; contains laminin, collagen typeVII, collagen type IV, and tenascin C (2).3.1.4 epidermal, adjpertaining to or resembling epidermis(1).3.1.5 epidermis, nthe outermost and nonvascularizedlayer of the skin (1).3.1.6 extracellular matrix, na structural and functionalentity produced by cells th

12、at surrounds and supports cells and1This test method is under the jurisdiction of ASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.41 on Classification and Terminology for TEMPs.Current edition approved Jan. 1, 2016. Published Februa

13、ry 2016. DOI: 10.1520/F3163-162For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3The boldface numbers in parent

14、heses refer to the list of references at the end ofthis standard.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1regulates cell communication. Typical components arecollagens, adhesive glycoproteins, glycosaminoglycans, andproteoglyca

15、ns (3).3.1.7 skin, nthe outer integument or covering of the body,consisting of the dermis and the epidermis, and resting uponthe subcutaneous tissue. (F2312)3.1.8 tissue, nan aggregation of similarly specialized cellsunited in the performance of a particular function. A tissuecontains an extracellul

16、ar matrix in addition to specialized cells(F2312)3.2 Skin Wound and Ulcer Definitions:3.2.1 acute wound, na wound that normally proceedsthrough an orderly and timely reparative/regenerative processthat results in sustained restoration of anatomic and functionalintegrity (4).3.2.2 arterial ulcer, nul

17、ceration due to peripheral arterialdisease (5).3.2.3 burn, ninjury to tissues caused by contact with heat,chemicals, electricity, friction, or radiant and electromagneticenergy (1).3.2.4 chronic wound, na wound that has failed to proceedthrough an orderly and timely process to produce anatomic andfu

18、nctional integrity, or proceeded through the repair processwithout establishing a sustained anatomic and functional result(4).3.2.5 full-thickness skin wound, na skin wound with theloss of epidermis and all of the dermis, or at least the depth ofdermis that includes most or all sources of epidermal

19、cells fromepidermal adnexae (glands and follicles). (F2312)3.2.6 lesion, nany pathological or traumatic discontinuityof tissue or loss of function of a part. (F2312)3.2.7 mixed arterial-venous ulcer, nan ulceration due to acombination of chronic venous insufficiency and arterial dis-ease (5).3.2.8 p

20、artial thickness skin wound, na skin wound withthe loss of the epidermis and part of the dermis, but retaininga layer of viable dermal tissue that includes the sources ofepidermal cells from which the wound can heal spontaneouslyby epidermal tissue regeneration. (F2312)3.2.9 scar, nfibrous tissue re

21、placing normal tissues de-stroyed by injury or disease. (F2312)3.2.10 surgical wound, na wound created as the result ofa surgical procedure.3.2.11 ulcer, na local defect, or excavation of the surfaceof an organ or tissue, which is produced by the sloughing ofinflammatory necrotic tissue. (F2312)3.2.

22、12 pressure ulcer, nlocalized injury to the skin and/orunderlying tissue usually over a bony prominence as a result ofpressure, or pressure in combination with shear and/or friction.Also known as decubital ulcer, decubitus ulcer, pressure sore,bed sore (6).3.2.13 diabetic ulcer, nan ulcer, usually o

23、f the lowerextremities and particularly of the foot, associated with diabe-tes mellitus (1).3.2.14 venous leg ulcer, nulceration on the leg due tochronic venous insufficiency. Also known as venous stasisulcer or venous insufficiency ulcer (5).3.2.15 wound, na disruption of normal anatomic structurea

24、nd function of a tissue or organ. Also known as injury ortrauma(4).3.2.15.1 DiscussionIn this guide, skin wounds includethose caused by burns, trauma, surgical incision, or surgicalexcision, in addition to ulcers associated with underlyingchronic conditions. This guide makes no distinction amongdiff

25、erent types of ulcers, which are a result of differingpathologies or conditions and for which different proceduresand different types of CTPs may be appropriate.3.3 Wound Healing Physiology Definitions:3.3.1 Acute wound healing of skin typically proceeds in asequential series of steps that overlap i

26、n time: hemostasis,inflammation, new tissue formation (re-epithelialization,granulation tissue formation, neovascularization), and tissueremodeling (wound contraction and extracellular matrix reor-ganization). Each of these steps is characterized by dynamic,reciprocal interactions among cells, extra

27、cellular matrix, andthe cellular microenvironment. In contrast, chronic wounds donot proceed normally through these healing steps but insteadexhibit numerous abnormalities as a result of underlyingpathobiology (7, 8).3.3.2 granulation tissue, nthe newly formed vasculartissue normally produced in the

28、 healing of wounds of softtissue and ultimately forming the cicatrix scar; it consists ofsmall, translucent, red, nodular masses or granulations thathave a velvety appearance. (F2312)3.3.3 heal, vto restore wounded parts or to make healthy.(F2312)3.3.4 healing, nthe restoration of integrity to injur

29、edtissue. (F2312)3.3.5 necrotic, adjcharacterized by the sum of the mor-phological changes indicative of cell death and caused by theprogressive degradative action of enzymes (1).3.3.6 scar, nfibrous tissue replacing normal tissues de-stroyed by injury or disease. (F2312)3.3.7 tissue regeneration, n

30、healing in which lost tissue isreplaced by migration, differentiation, and proliferation of cellsthat deposit new extracellular matrix with normal architecture,function, and appearance.3.3.8 tissue repair, nhealing in which lost tissue is re-placed by a fibrous scar, which is produced from granulati

31、ontissue. (F2312)3.3.9 wound contraction, nthe shrinkage and spontaneousclosure of open skin wounds. (F2312)3.3.10 wound contracture, na condition of fixed highresistance to passive stretch of muscle, skin or joints resultingfrom fibrosis and scarring of the skin or the tissues supportingthe muscles

32、 or the joints, or both.3.3.10.1 DiscussionThis definition is a modification ofDorlands definition of contracture, “a condition of fixed highresistance to passive stretch of muscle, resulting from fibrosisof the tissues supporting the muscles or the joints, or disordersF3163 162of the muscle fibers,

33、” (1) because that definition does notaddress fibrosis and scarring in skin. (F2312)3.3.11 wound inflammation, na localized protective re-sponse elicited by injury or destruction of tissues, which servesto destroy, dilute, or wall off (sequester) both the injuriousagent and the injured tissue. It is

34、 characterized in the acuteform by the classical signs of pain (dolor), heat (calor) redness(rubor), swelling (tumor), and loss of function (functio laesa).Histologically, it involves a complex series of events, includingdilation of arterioles, capillaries, and venules, with increasedpermeability an

35、d blood flow; exudation of fluids, includingplasma proteins; and leukocytic migration into the inflamma-tory focus. (F2312)3.4 Wound Cover Definitions:3.4.1 dressing, nany of various materials utilized to coverand protect wounds. (F2312)3.4.2 surgical dressing, nany of various materials utilizedto c

36、over and protect wounds following surgical procedures ordebridement of any type.3.5 CTP Components and Methods:3.5.1 acellular scaffold, na scaffold without primary orcultured cells. (F2311)3.5.2 allogeneic or allogenic, adjfrom cells, tissues, andorgans in which the donor and recipient are genetica

37、llydifferent individuals of the same species. (F2311)3.5.3 autologous, adjfrom cells, tissues, and organs inwhich the donor and recipient is the same individual. (F2311)3.5.4 bioactive agent, nany molecular component thatelicits a tissue or cell response.3.5.5 biocompatible, adjthe ability of a mate

38、rial to per-form with an appropriate host response in a specific situation(9).3.5.6 biological, adjsynthesized or produced by livingcells.3.5.7 biomaterial, nany substance (other than a drug),synthetic or natural, that can be used as a system or part of asystem that treats, augments, or replaces any

39、 tissue, organ, orfunction of the body. (F2312)3.5.8 biosynthetic, adjpartly synthesized or produced byliving cells and partly chemically synthesized.3.5.9 cell, nthe smallest structural and functional unit ofan organism. Typically, cells are microscopic and consist ofcytoplasm and a nucleus enclose

40、d in a membrane (10).3.5.10 cell culture, nthe in vitro growth or maintenance ofcells. (F2311)3.5.11 cell type, na distinct morphological or functionalform of cell. (F2311)3.5.12 cellular, adjcontaining viable (living) cells.3.5.13 cellular and/or tissue-based product (CTP), naproduct defined primar

41、ily by its composition, comprising cellsand/or the extracellular components of tissue. CTPs maycontain cells (viable or nonviable), tissues, proteins, and othermaterials for which there is a rationale for benefit beyond thatachievable with conventional wound coverings. CTPs mayadditionally include s

42、ynthetic components. Whether an indi-vidual CTP is capable of promoting wound healing must bedetermined by adequate evidence and is beyond the scope ofthis standard.3.5.14 cellular therapy, na treatment containing viable(living) cells.3.5.15 cellularized scaffold, na scaffold that has beenseeded wit

43、h viable cells. The seeded scaffold may or may notbe further cultured. (F2311)3.5.16 CTP product format, nthe overall shape or appear-ance of the CTP, which includes, but is not limited to, singlesheets, multilayer sheets, 3-dimensional constructs, particles(e.g., powders), granules, gels, sprays, p

44、ellets, spheroids,cylinders, and so forth.3.5.17 cultured cells, ncells propagated by cell culture.(F2311)3.5.18 decellularized scaffold, nan acellular scaffoldformed by removing the cells from an extracellular matrix bychemical and physical treatments. (F2311)3.5.19 devitalized scaffold, na tissue-

45、derived scaffold con-taining killed cells and no viable cells.3.5.20 differentiated cell, ncell with morphological andmetabolic characteristics of a specialized type.3.5.21 extracellular matrix architecture, nstructural char-acteristics of an extracellular matrix.3.5.22 killed cell, na cell that has

46、 been subjected tophysical or chemical conditions that assure that it is non-viable.(F2311)3.5.23 live cell, na viable cell. (F2311)3.5.24 metabolically active, adjcapable of catalyzing allof the chemical transformations and transport processes typicalof living organisms, including anabolism and cat

47、abolism.Metabolic processes typically transform small molecules, butalso include macromolecular processes such as DNArepair andreplication, protein synthesis and degradation, and membranetransport. (F2311)3.5.25 natural materials, nsynthesized or produced byliving cells. (F2027)3.5.26 non-viable cel

48、l, na cell that does not meet thedefinition of viability specified in 3.5.35. (F2311)3.5.27 primary cells, ndispersed cells derived directlyfrom fresh tissue. (F2311)3.5.28 processed, adjcharacterized by a series of me-chanical or chemical operations on (something) in order tochange or preserve it.

49、In this standard, processed is used torefer to tissue (as in processed tissue) (10).3.5.29 proliferation competent cell, ncell capable of rep-lication.3.5.30 scaffold, na support, delivery vehicle, or matrix forfacilitating the migration, binding, or transport of cells orbioactive molecules used to replace, repair, or regeneratetissues. (F2150)3.5.31 scaffold architecture, nmacrostructural characteris-tics of a scaffold biomaterial that determines its permeability toF3163 163cells, including whether or not it is