Are FDA and CE sacrificing safety for a faster commercialization of xenogeneic tissue devices? Unavoidable need for legislation in decellularized tissue manufacturing

NasoF.; IopL.; SpinaM.; GerosaG.

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Are FDA and CE sacrificing safety for a faster commercialization of xenogeneic tissue devices? Unavoidable need for legislation in decellularized tissue manufacturing

机译：FDA和CE是否在牺牲安全性以更快地将异种组织设备商业化？脱细胞组织生产中不可避免的立法需求

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The critical shortage of human organs available for transplant led biomedical researchers to explore the use of animal donors as an attractive and unlimited source of biological devices to treat a wide range of human disorders (xenotransplantation). In order to be intended for clinical use, scaffolds derived from non-human mammalian tissues are subjected either to glutaraldehyde treatment to induce an immunological barrier or to decellularization procedures which should ensure the removal of resident cellular components, as antigens and nucleic acids.

机译：可移植的人体器官严重短缺，导致生物医学研究人员探索使用动物供体作为治疗广泛的人类疾病（异种移植）的有吸引力且无限的生物设备来源。为了用于临床用途，对源自非人类哺乳动物组织的支架进行戊二醛处理以诱导免疫屏障或进行脱细胞程序，该程序应确保除去驻留的细胞成分，如抗原和核酸。

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《Tissue antigens.》 |2014年第3期|共2页
作者
NasoF.; IopL.; SpinaM.; GerosaG.;
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正文语种 eng
中图分类人体形态学;
关键词
AlphaGal; Biomaterials; Food and drug administration; Xenoantigen;

机译：AlphaGal;生物材料;食品和药物管理局;异种抗原;

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1. Are FDA and CE sacrificing safety for a faster commercialization of xenogeneic tissue devices? Unavoidable need for legislation in decellularized tissue manufacturing [J] . NasoF., IopL., SpinaM., Tissue antigens. . 2014,第3期

机译：FDA和CE是否在牺牲安全性以更快地将异种组织设备商业化？脱细胞组织生产中不可避免的立法需求
2. Impact of decellularization of xenogeneic tissue on extracellular matrix integrity for tissue engineering of heart valves [J] . Schenke-Layland K, Vasilevski O, Opitz F, Journal of Structural Biology . 2003,第3期

机译：异源组织去细胞化对心脏瓣膜组织工程细胞外基质完整性的影响
3. The immune response to crosslinked tissue is reduced in decellularized xenogeneic and absent in decellularized allogeneic heart valves [J] . Boeer Ulrike, Schridde Ariane, Anssar Marcel, The international journal of artificial organs . 2015,第4期

机译：在脱细胞异种中，对交联组织的免疫反应降低，而在脱细胞异体心脏瓣膜中则不存在
4. Decellularized Extracellular Matrix Derived from Porcine Adipose Tissue as a Potential Biomaterial for Xenogeneic Tissue Engineering [C] . Young Chan Choi, Hwa In Yoon, Ji Suk Choi, World biomaterials congress . 2012

机译：猪脂肪组织的脱细胞细胞外基质作为异种组织工程的潜在生物材料
5. Safety and performance considerations for interactions between electromagnetic fields and biological tissue: Applications to high field human magnetic resonance imaging and tissue-implanted devices. [D] . Tang, Lin. 2010

机译：电磁场与生物组织之间相互作用的安全性和性能考虑：在高场人体磁共振成像和组织植入设备中的应用。
6. Decellularized Extracellular Matrix Derived from Porcine Adipose Tissue as a Xenogeneic Biomaterial for Tissue Engineering [O] . Young Chan Choi, Ji Suk Choi, Beob Soo Kim, -1

机译：猪脂肪组织的脱细胞细胞外基质作为组织工程的异种生物材料
7. Tissue engineering of heart valves using decellularized xenogeneic or polymeric starter matrices [O] . Schmidt, Dörthe, Stock, Ulrich A, Hoerstrup, Simon P 2007

机译：使用脱细胞异种或聚合起始剂基质进行心脏瓣膜的组织工程
8. Human Tissue Banks: FDA Taking Steps to Improve Safety, but Some Concerns Remain [R] . 1997

机译：人体组织银行：FDa采取措施提高安全性，但仍存在一些问题

Are FDA and CE sacrificing safety for a faster commercialization of xenogeneic tissue devices? Unavoidable need for legislation in decellularized tissue manufacturing

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