Decellularized human valve allografts

Elkins, Ronald C.; Dawson, Patti E.; Goldstein, Steven A.; Walsh, Steven P; Black, Kirby S.

doi:10.1016/s0003-4975(01)02503-6

Cited by 194 publications

(128 citation statements)

References 7 publications

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“…It has become increasingly clear that the assumption that xenoantigens are likely to be cell-associated is not valid. Our findings further emphasize that treatment of unfixed xenogeneic tissues for tissue engineering applications must shift from a paradigm of "decellularization" to one of "antigen removal" [9][10][11][12][14][15][16][17][18][19][20][21][22][23][24][25][26]. Current or future antigen removal or antigen masking treatments will need to account for both cellular and extracellular matrix antigens.…”

Section: Discussionmentioning

confidence: 99%

“…Because tissues are unfixed in this application, it is necessary to remove graft antigenicity prior to implantation. Numerous physical and chemical treatments designed to decrease the immunogenicity of unfixed xenogeneic biomaterials have been investigated [9,11,12,[14][15][16][17][18][19][20][21][22][23][24][25][26]. These treatments have generally been characterized as tissue "decellularization", based on the assumption that antigens mediating an immune response to the graft would likely be cell-associated.…”

Section: Introductionmentioning

confidence: 99%

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Immunoproteomic identification of bovine pericardium xenoantigens

et al. 2008

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Bovine pericardium is an important biomaterial with current application in glutaraldehyde-fixed bioprosthetic heart valves and possible future application as an unfixed biological scaffold for tissue engineering. The importance of both humoral and cell-mediated rejection responses toward fixed and unfixed xenogeneic tissues has become increasingly apparent. However, the full scope and specific identities of bovine pericardium proteins that can elicit an immune response remain largely unknown. In this study, an immunoproteomic approach was used to survey bovine pericardium proteins for their ability to elicit a humoral immune response in rabbits. A two-stage protein extraction protocol was used to separate bovine pericardium proteins into water-and lipid-soluble fractions. Two-dimensional gel electrophoresis was performed to separate the proteins from each fraction. Western blots were generated from two-dimensional gels of both bovine pericardium protein fractions. These blots were probed with serum from rabbits immunized with bovine pericardium and a secondary antibody was used to assess for IgG positivity. Western blots were compared to duplicate two-dimensional gels and proteins in matched spots were identified by tandem mass spectrometry. Thirty-one putative protein antigens were identified, eight of which are known to be antigenic from previous studies. All of the putative antigens demonstrated progressive staining intensity with increasing days of post-exposure serum. Identified antigenic proteins represented a variety of functional and structural protein types, and included both cellular and matrix proteins. The results of this study have implications for the use of bovine pericardium as a biomaterial in bioprostheses and tissue engineering applications, as well as xenotransplantation in general.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Immunoproteomic identification of bovine pericardium xenoantigens

et al. 2008

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“…The Synergraft process uses hypotonic cell lysis, nuclease digestion and isotonic washes but does not incorporate a detergent wash (Gerson et al ., 2012; O’Brien et al ., 1999; Zehr et al ., 2005). The process has, however, been reported to reduce MHC immunoreactivity markedly, indicating reduction in membrane proteins (Elkins et al ., 2001b). The process described by da Costa et al (2010) uses 0.1% ( w / v ) SDS and washing in isotonic Ringer lactate, but does not mention the use of nuclease and the process described by the Haverich group (Cebotari et al ., 2011; Neumann et al ., 2014) incorporates a harsher detergent treatment (0.5% w / v SDS plus 0.5% w / v sodium deoxycholate) but again does not appear to incorporate a nuclease treatment (Cebotari et al ., 2011).…”

Section: Discussionmentioning

confidence: 99%

“…This proprietary process involves cell lysis induced by incubation in water and nuclease digestion followed by a multiday isotonic wash‐out phase (Gerson et al ., 2012; O’Brien et al ., 1999). Near complete removal of cells and cellular components was demonstrated through histological and immunocytochemical analysis with no corresponding change in the in vitro biomechanics (Elkins et al ., 2001b). The CryoValve SG™ pulmonary valve has subsequently been reported to perform well clinically in the short to mid‐term and outcomes in adults and children with a mean follow‐up of 4 years have been comparable to (Bechtel et al ., 2005, 2008; Brown et al ., 2010; Burch et al ., 2010; Hawkins et al ., 2003) or better than (Konuma et al ., 2009; Ruzmetov et al ., 2012; Tavakkol et al ., 2005) conventional cryopreserved human pulmonary allografts.…”

Section: Introductionmentioning

confidence: 99%

Decellularization of human donor aortic and pulmonary valved conduits using low concentration sodium dodecyl sulfate

Vafaee

Thomas

Desai

et al. 2017

J Tissue Eng Regen Med

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The clinical use of decellularized cardiac valve allografts is increasing. Long‐term data will be required to determine whether they outperform conventional cryopreserved allografts. Valves decellularized using different processes may show varied long‐term outcomes. It is therefore important to understand the effects of specific decellularization technologies on the characteristics of donor heart valves. Human cryopreserved aortic and pulmonary valved conduits were decellularized using hypotonic buffer, 0.1% (w/v) sodium dodecyl sulfate and nuclease digestion. The decellularized tissues were compared to cellular cryopreserved valve tissues using histology, immunohistochemistry, quantitation of total deoxyribose nucleic acid, collagen and glycosaminoglycan content, in vitro cytotoxicity assays, uniaxial tensile testing and subcutaneous implantation in mice. The decellularized tissues showed no histological evidence of cells or cell remnants and >97% deoxyribose nucleic acid removal in all regions (arterial wall, muscle, leaflet and junction). The decellularized tissues retained collagen IV and von Willebrand factor staining with some loss of fibronectin, laminin and chondroitin sulfate staining. There was an absence of major histocompatibility complex Class I staining in decellularized pulmonary valve tissues, with only residual staining in isolated areas of decellularized aortic valve tissues. The collagen content of the tissues was not decreased following decellularization however the glycosaminoglycan content was reduced. Only moderate changes in the maximum load to failure of the tissues were recorded postdecellularization. The decellularized tissues were noncytotoxic in vitro, and were biocompatible in vivo in a mouse subcutaneous implant model. The decellularization process will now be translated into a good manufacturing practices‐compatible process for donor cryopreserved valves with a view to future clinical use. Copyright © 2016 The Authors Tissue Engineering and Regenerative Medicine published by John Wiley & Sons, Ltd.

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“…Existing evidence suggests that decellularization of biomaterials makes the tissue less antigenic, reducing the inflammatory response and causing less tissue degeneration [12][13][14]. However, until now, the decellularization process of bovine pericardium has not been studied with the objective of producing heart bioprostheses.…”

Section: Introductionmentioning

confidence: 99%

Comparação entre o pericárdio bovino decelularizado e o pericárdio bovino convencional utilizado na confecção de biopróteses valvares cardíacas

Costa¹,

Pomerantzeff²,

Braile³

et al. 2005

Rev Bras Cir Cardiovasc

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Introduction: In this paper, our objective was to compare the decellularized and conventional pericardium mechanical resistance and also its capability of inducing inflammatory response in an animal experimental model.Methods: In order to study these properties, we divided the pericardia into two groups: Group I -pericardium conventionally treated with GTA and Group II -pericardium previously decellularized and then treated with GTA in the conventional way. After the chemical treatment, Group II samples were histologically evaluated to confirm the efficacy of the decellularization process. Then, only for the analysis of mechanical resistance, pericardia were divided in: Groups 1 (conventional pericardia with criteria of approval), 2 (conventional pericardial with criteria of rejection) and 3 (decellularized pericardia). The capacity of inducing inflammatory response was tested in a rat experimental model using 50 Wistar rats, in which rats of each group received patches of the pericardia in the abdomen. Our third step of analysis was to manufacture three decellularized pericardium bioprostheses which were submitted to hydrodynamic evaluation together with a conventional bioprosthesis test.Results: The histological analysis showed complete decellularization. Mechanical resistance gave statistical differences in the "tension of rupture" and "tenacity index" tests. We found no difference in the inflammatory activity in the animal model. Hydrodynamic performance was similar and all prostheses reached 150 million cycles. The final histological analysis assessed the standard microscopic pattern and no rupture or abnormal fragmentation was caused by mechanical stress. Conclusion:The decellularization technique maintains the physical resistance of the pericardium when compared with the conventionally prepared pericardium. And also, there was no difference in both groups regarding to inflammatory response studied in the animal model. Descriptors: Heart valve prosthesis. Bioprosthesis. Pericarduim. Comparative study. Comparação entre o pericárdio bovino decelularizado e o pericárdio bovino convencional utilizado na confecção de biopróteses valvares cardíacasComparison between the decellularized bovine pericardium and the conventional bovine pericardium used in the manufacture of cardiac bioprostheses 15 COSTA, JNL ET AL -Comparison between the decellularized bovine pericardium and the conventional bovine pericardium used in the manufacture of cardiac bioprostheses Braz J Cardiovasc Surg 2005; 20(1):14-22

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Decellularized human valve allografts

Cited by 194 publications

References 7 publications

Immunoproteomic identification of bovine pericardium xenoantigens

Immunoproteomic identification of bovine pericardium xenoantigens

Decellularization of human donor aortic and pulmonary valved conduits using low concentration sodium dodecyl sulfate

Comparação entre o pericárdio bovino decelularizado e o pericárdio bovino convencional utilizado na confecção de biopróteses valvares cardíacas

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