[1] ASTM F 3354 2019 Standard Guide for Evaluating Extracellular Matrix Decellularization Processes: American Society for Testing and Materials[S].2019
[2] HUSSEY GS, DZIKI JL, BADYLAK SF. Extracellular matrix-based materials for regenerative medicine[J].Nat Rev Mater, 2018, 3(7): 159
[3] SAFDARI M, BIBAK B, SOLTANI H, et al. Recent advancements in decellularized matrix technology for bone tissue engineering[J].Differentiation, 2021, 121(2): 25
[4] CONROY C, SETHI P, MACKEN C, et al. Augmentation of distal biceps repair with an acellular dermal graft restores native biomechanical properties in a tendon-deficient model[J].Am J Sports Med, 2017, 45(9): 2028
[5] ZHU M, LI W, DONG X, et al. In vivo engineered extracellular matrix scaffolds with instructive niches for oriented tissue regeneration[J].Natu Com, 2019, 10(1): 1
[6] ZHANG W, DU A, LIU S, et al. Research progress in decellularized extracellular matrix-derived hydrogels[J].Regen Ther, 2021, 18(4): 88
[7] CALAFIORE AM, HAVERICH A, GAUDINO M, et al. Immunoreaction to xenogenic tissue in cardiac surgery: alpha-Gal and beyond[J].Eur J Cardio Surg, 2022, 62(1): 115
[8] 国家药品监督管理局. 食品药品监管总局关于发布动物源性医疗器械注册技术审查指导原则(2017年修订版)的通告(2017年第224号) [EB/OL]. [2018-01-05]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20180105112501619.html, 2017-12-25
State Drug Administration. CFDA Announcement on Issuing the Guidelines for Technical Review of Animal Origin Medical Device Registration (2017 Revised Edition) (2017 No.224) [EB/OL]. [2018-01-05]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20180105112501619.html, 2017-12-25
[9] Guidance for Industry and Food and Drug Administration Staff. Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices)(MARCH 2019) [EB/OL]. [2019-03-15]. https://www.regulations.gov/document/FDA-2013-D-1574-0014, 2019-03-15
[10] BALABIYEV A, PODOLNIKOVA NP, KILBOURNE JA, et al. Fibrin polymer on the surface of biomaterial implants drives the foreign body reaction[J].Biomaterials, 2021, 277(12): 121087
[11] KÄMMERLING L, FISHER LE, ANTMEN E, et al. Mitigating the foreign body response through ‘immune-instructive’ biomaterials[J].J Immu Rege Med, 2021, 12(23): 100040
[12] ROWLEY AT, NAGALLA RR, WANG SW, et al. Extracellular matrix-based strategies for immunomodulatory biomaterials engineering[J].Adv Health Mater, 2019, 8(8): 1801578
[13] MARIANI E, LISIGNOLI G, BORZI RM, et al. Biomaterials: foreign bodies or tuners for the immune response?[J].Int J Mol Sci, 2019, 20(3): 45
[14] KIZHAKKEDATHU JN, CONWAY EM. Biomaterial and cellular implants: foreign surfaces where immunity and coagulation meet[J].Blood, 2022, 139(13): 1987
[15] JAFFER IH, WEITZ JI. The blood compatibility challenge. Part 1. Blood-contacting medical devices the scope of the problem[J].Acta Biomater, 2019, 94(3): 2
[16] MARIANI E, LISIGNOLI G, BORZI RM, et al. Biomaterials: foreign bodies or tuners for the immune response[J].Int J Mol Sci, 2019, 20(3): 636
[17] ZHANG L, CAO Z, BAI T, et al. Zwitterionic hydrogels implanted in mice resist the foreign-body reaction[J].Nat Biotechnol, 2013, 31(6): 553
[18] FRAZO LP, VIEIRA D, NEVES NM. In vivo evaluation of the biocompatibility of biomaterial device[J]. Biomimicked Biomaterials, 2020, 1250(1):109
[19] XIAOXIAO W, SIBIAO Y, XIAOPENG X, et al. Neutrophils induce the maturation of immature dendritic cells: a regulatory role of neutrophils in adaptive immune responses[J].Immunol Invest, 2007, 36(3): 337
[20] SHEN M, GARCIA I, MAIER RV, et al. Effects of adsorbed proteins and surface chemistry on foreign body giant cell formation, tumor necrosis factor alpha release and procoagulant activity of monocytes[J].J Biomed Mater Res A, 2004, 70(4): 533
[21] BRODBECK WG, MACEWAN M, COLTON E, et al. Lymphocytes and the foreign body response: lymphocyte enhancement of macrophage adhesion and fusion[J].J Biomed Mater Res A, 2005, 74(2): 222
[22] KIM MS, LIM HG, KIM YJ. Calcification of decellularized and alpha-galactosidase-treated bovine pericardial tissue in an alpha-Gal knock-out mouse implantation model: comparison with primate pericardial tissue[J].Eur J Cardiothorac Surg, 2016, 49(3): 894
[23] LEE C, AHN H, KIM SH, et al. Immune response to bovine pericardium implanted into alpha1, 3-galactosyltransferase knockout mice: feasibility as an animal model for testing efficacy of anticalcification treatments of xenografts[J].Eur J Cardio Surg, 2012, 42(1): 164
[24] HARA H, COOPER DK. The immunology of corneal xenotransplantation: a review of the literature[J].Xenotransplantation, 2010, 17(5): 338
[25] GIBSON T, MEDAWAR PB. The fate of skin homografts in man[J].J Anatomy, 1943, 77(Pt 4): 299
[26] COOPER DKC, EKSER B, TECTOR AJ. Immunobiological barriers to xenotransplantation[J].Int J Surg, 2015, 23(Pt B): 211
[27] KOBAYASHI T, COOPER DK. Anti-Gal, alpha-Gal epitopes, and xenotransplantation[J].Sub Bio, 1999, 32(2): 229
[28] GALILI U. Evolution of alpha 1, 3 galactosyltransferase and of the alpha-Gal epitope[J].Sub Bio, 1999, 32(1): 1
[29] GALILI U, SWANSON K. Gene sequences suggest inactivation of alpha-1, 3-galactosyl transferase in catarrhines after the divergence of apes from monkeys[J].Proc Natl Acad Sci USA, 1991, 88(16): 7401
[30] GALILI U. Evolution and pathophysiology of the human natural anti-α-galactosyl IgG (anti-Gal) antibody[C].Springer Seminars in Immunopathology. Springer-Verlag, 1993, 15: 155
[31] GALILI U. Interaction of the natural anti-Gal antibody with α-galactosyl epitopes: a major obstacle for xenotransplantation in humans[J].Immun Today, 1993, 14(10): 480
[32] GALILI U, RACHMILEWITZ EA, PELEG A, et al. A unique natural human IgG antibody with anti-alpha-galactosyl specificity[J].J Exp Med, 1984, 160(5): 1519
[33] GALILI U. Avoiding detrimental human immune response against Mammalian extracellular matrix implants[J].Tissue Eng Part B Rev, 2015, 21(2): 231
[34] MA D, HIROSE T, LASSITER G, et al. Kidney transplantation from triple-knockout pigs expressing multiple human proteins in cynomolgus macaques[J].Am J Transplant, 2022, 22(1): 46
[35] DEEKEN CR, ELIASON BJ, PICHERT MD, et al. Differentiation of biologic scaffold materials through physicomechanical, thermal, and enzymatic degradation techniques[J].Ann Surg, 2012, 255(3): 595
[36] MEYER M. Processing of collagen based biomaterials and the resulting materials properties[J].Biomed Eng Online, 2019, 18(1): 24
[37] CAPELLA-MONSONÍS H, ZEUGOLIS DI. Decellularized xenografts in regenerative medicine: from processing to clinical application[J].Xenotrans, 2021, 28(4): e12683
[38] FISCHER K, SCHNIEKE A. Extensively edited pigs[J].Nat Biomed Eng, 2021, 5(2): 128
[39] LAI LX, KOLBER-SIMONDS D, PARK KW, et al. Production of alpha-1, 3-galactosyltransferase knockout pigs by nuclear transfer coning[J].Science, 2002, 295(5557): 1089
[40] PHELPS CJ, KOIKE C, VAUGHT TD, et al. Production of alpha 1, 3-galactosyltransferase-deficient pigs[J].Science, 2003, 299(5605): 411
[41] CHEN Y, STEWART JM, GUNTHART M, et al. Xenoantibody response to porcine islet cell transplantation using GTKO, CD55, CD59, and fucosyltransferase multiple transgenic donors[J].Xenotransplantation, 2014, 21(3): 244
[42] HOU N, XU X, LV D, et al. Tissue-engineered esophagus: recellular esophageal extracellular matrix based on perfusion-decellularized technique and mesenchymal stem cells[J].Biomed Mater, 2021, 16(5): 23
[43] GB/T 16886.6-2015 医疗器械生物学评价 第6部分:植入后局部反应试验[S].2015
GB/T 16886.6-2015 Biological Evaluation of Medical Devices Part 6:Tests for Local Effects After Implantation[S].2015
[44] GB/T 16886.20-2015 医疗器械生物学评价 第20部分:医疗器械免疫毒理学试验原则和方法[S].2015
GB/T 16886.20-2015 Biological Evaluation of Medical Devices Part 20:Principles and Methods for Immunotoxicology Testing of Medical Devices[S].2015
[45] 徐丽明, 邵安良, 赵艳红. 动物源性生物材料残留DNA的定量检测法[J].生物医学工程学杂志, 2012, 29(3): 7
XU LM, SHAO AL, ZHAO YH. Quantitative detection method for residual DNA of animal-derived biological materials[J].J Biomed Eng, 2012, 29(3): 7
[46] LU Y, SHAO A, SHAN Y, et al. A standardized quantitative method for detecting remnant alpha-Gal antigen in animal tissues or animal tissue-derived biomaterials and its application[J].Sci Rep, 2018, 8(1): 15424
[47] BOUSSAMET L, MONTASSIER E, SOULILLOU JP, et al. Anti α1-3 Gal antibodies and Gal content in gut microbiota in immune disorders and multiple sclerosis[J].Clin Immunol, 2022, 235(1): 108693
[48] GALILI U, LATEMPLE DC, RADIC MZ. A sensitive assay for measuring alpha-Gal epitope expression on cells by a monoclonal anti-Gal antibody[J].Transplantation, 1998, 65(8): 1129
[49] 吴勇, 邵安良, 徐晓莉, 等. α-Gal抗原定量检测试剂盒的研发[J].药物分析杂志, 2017, 37(10): 178
WU Y, SHAO AL, XU XL, et al. Development of α-Gal antigen quantitative detection Kit[J].Chin J Pharm Anal, 2017, 37(10): 178
[50] 王金恒, 邵安良, 徐丽明, 等. 一种α-Gal抗原快速检测试剂盒及其使用方法和应用:中国,CN108872584A[P].2018-11-23
WANG JH, SHAO AL, XU LM, et al. A rapid detection kit for α-Gal antigen and its use method and application:China,CN108872584A[P].2018-11-23
[51] YY/T 1561-2017 组织工程医疗器械产品 动物源性支架材料残留α-Gal抗原检测[S].2017
YY/T 1561-2017 Tissue Engineering Medical Device Products Remnant α-Gal Antigen Determination in Scaffold Materials Utilizing Animal Tissues and Their Derivatives[S].2017
[52] LOPEZ-MARTINEZ S, CAMPO H, DE MIGUEL-GOMEZ L, et al. A natural xenogeneic endometrial extracellular matrix hydrogel toward improving current human in vitro models and future in vivo applications[J].Front Biotechnol, 2021, 9(9): 639688
[53] CESUR NP, YALMAN V, LAÇĪN MT. Decellularization of cow aorta via supercritical CO2[J].J Appl Biol Sci, 2020, 14(3): 268
[54] WANG Z, SUN F, LU Y, et al. Rapid preparation of decellularized trachea as a 3D scaffold for organ engineering[J].Int J Artif Organs, 2021, 44(1): 55
[55] WOODS T, GRATZER PF. Effectiveness of three extraction techniques in the development of a decellularized bone-anterior cruciate ligament-bone graft[J].Biomaterials, 2005, 26(35): 7339
[56] CAO G, LI X. The Decellularization of Tissues, Decellularized Materials[M].Singapore: Springer, 2021: 69
[57] TANG D, KANG R, COYNE CB, et al. PAMP s and DAMPs: signal 0s that spur autophagy and immunity[J].Immunol Rev, 2012, 249(1): 158
[58] YY/T 0606.15-2014 组织工程医疗产品 第15部分:评价基质及支架免疫反应的试验方法—淋巴细胞增殖试验[S].2014
YY/T 0606.15-2014 Tissue Engineered Medical Products Part 15:Standard Practice for Evaluation of Immune Responses of Substrate and Scaffolds Products—Lymphocyte Proliferation Tests[S].2014
[59] YY/T 1465.1-2016 医疗器械免疫原性评价方法 第1部分:体外T淋巴细胞转化试验[S].2016
YY/T 1465.1-2016 Immunogenic Evaluation Method of Medical Devices Part 1:T Lymphocyte Transformation Test in vitro [S].2016
[60] 邵安良, 穆钰峰, 屈树新, 等. 人外周血淋巴细胞增殖试验的优化及其应用[J].药物分析杂志, 2019, 39(8): 1354
SHAO AL, MU YF, QU SX, et al.Optimization and application of human peripheral blood lymphocyte proliferation test[J].Chin J Pharm Anal, 2019, 39(8): 1354
[61] 陈亮, 穆钰峰, 邵安良, 等. 动物源性生物材料体外淋巴细胞增殖试验方法的建立[J].药物分析杂志, 2019, 39(8): 1339
CHEN L, MU YF, SHAO AL, et al. Establishment of a lymphocyte proliferation test method in vitro for animal-drived biomaterials[J].Chin J Pharm Anal, 2019, 39(8): 1339
[62] 陈亮, 穆钰峰, 邵安良, 等. 不同种属小鼠用于淋巴细胞增殖试验的比较研究[J].药物分析杂志, 2019, 39(8): 1347
CHEN L, MU YF, SHAO AL, et al. Comparative study on lymphocyte proliferation test in mice of different species [J].Chin J Pharm Anal, 2019, 39(8): 1347
[63] THALL AD, MALY P, LOWE JB. Oocyte Gal alpha 1, 3Gal epitopes implicated in sperm adhesion to the zona pellucida glycoprotein ZP3 are not required for fertilization in the mouse[J].J Biol Chem, 1995, 270(37): 21437
[64] TEARLE RG, TANGE MJ, ZANNETTINO ZL, et al. The alpha-1, 3-galactosyltransferase knockout mouse. Implications for xenotransplantation[J].Transplantation, 1996, 61(1): 13
[65] OGAWA H, MOHIUDDIN MM, YIN DP, et al. Mouse-heart grafts expressing an incompatible carbohydrate antigen. Ⅱ. Transition from accommodation to tolerance[J].Transplantation, 2004, 77(3): 366
[66] SHAO A, LING Y, XU L, et al. Xenogeneic bone matrix immune risk assessment using GGTA1 knockout mice[J].Artif Cells Nanomed Biotechnol, 2018, 46(Suppl 3): S359
[67] 邵安良, 魏利娜, 范昌发, 等. 2种Gal抗原缺失小鼠的免疫学特性比较研究[J].药物分析杂志, 2018, 38(8): 10
SHAO AL, WEI LN, FAN CF, et al. Comparative study on immunological characteristics of two gal antigen-deficient mice[J].Chin J Pharm Anal, 2018, 38(8): 10
[68] 王泽昊, 邵安良, 魏利娜, 等. 采用Gal抗原缺失鼠评价GGTA1/B4GalNT2/CMAH基因敲除猪软骨组织的免疫原性[J].解放军医学院学报, 2019, 40(6): 4
WANG ZH, SHAO AL, WEI LN, et al. Using Gal antigen-deficient mice to evaluate the immunogenicity of GGTA1/B4GalNT2/CMAH gene knockout pig cartilage tissue[J].Acad J Chin PLA Med Sch, 2019, 40(6): 4
[69] 陈亮, 邵安良, 魏利娜, 等. 应用Gal抗原缺失小鼠评价可降解异种脱细胞真皮基质的免疫原性[J].药物分析杂志, 2019, 39(8): 1370
CHEN L, SHAO AL, WEI LN, et al. Evaluation of the immunogenicity of degradable xenogeneic acellular dermal matrix using Gal antigen-deficient mice[J].Chin J Pharm Anal, 2019, 39(8): 1370
[70] 魏利娜, 邵安良, 黄立静, 等. 去细胞异种角膜基质与去细胞异种结膜基质的免疫原性研究[J].药物分析杂志, 2019, 39(8):1362
WEI LN, SHAO AN, HUANG LJ, et al. Study on the immunogenicity of acellular xenogeneic corneal stroma and acellular xenogeneic conjunctival matrix[J].Chin J Pharm Anal, 2019, 39(8):1362
[71] CHEN L, WEI L, SHAO A, et al. Immune risk assessment of residual alpha Gal in xenogeneic decellularized cornea using GTKO mice[J].Regen Biomater, 2020, 7(4): 427
[72] MU Y, SHAO A, SHI L, et al. Immunological risk assessment of xenogeneic dural patch by comparing with raw material via GTKO mice[J].Biomed Res Int, 2022, 7950834. DOI: https://doi.org/10.1155/2022/7950834
[73] 穆钰峰, 魏利娜, 吴勇, 等. α-半乳糖基抗原缺失模型兔的研制与评价[J].中国组织工程研究, 2021, 25(2): 281
MU YF, WEI LN, WU Y, et al. Development and evaluation of alpha-galactosyl antigen-deficient rabbit model[J].Chin J Tissue Eng Res, 2021, 25(2): 281
[74] WEI L, MU Y, DENG J, et al. α-Gal antigen-deficient rabbits with GGTA1 gene disruption via CRISPR/Cas9[J].BMC Genomic Data, 2022, 23(1): 1
