دورية أكاديمية

Advantages and challenges in processing and quality control of decellularized heart valves.

التفاصيل البيبلوغرافية
العنوان: Advantages and challenges in processing and quality control of decellularized heart valves.
المؤلفون: Lux M; Corlife oHG, Feodor-Lynen-Str. 23, 30625, Hannover, Germany. marco.lux@corlife.eu., Haller R; Corlife oHG, Feodor-Lynen-Str. 23, 30625, Hannover, Germany., Giere B; Corlife oHG, Feodor-Lynen-Str. 23, 30625, Hannover, Germany., Lindner B; Corlife oHG, Feodor-Lynen-Str. 23, 30625, Hannover, Germany., Harder M; Corlife oHG, Feodor-Lynen-Str. 23, 30625, Hannover, Germany., Mastrobuoni S; Cliniques Universitaires Saint-Luc, European Homograft Bank, Brussels, Belgium., Jashari R; Cliniques Universitaires Saint-Luc, European Homograft Bank, Brussels, Belgium.
المصدر: Cell and tissue banking [Cell Tissue Bank] 2024 Mar; Vol. 25 (1), pp. 43-53. Date of Electronic Publication: 2023 May 03.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: Kluwer Academic Publishers Country of Publication: Netherlands NLM ID: 100965121 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1573-6814 (Electronic) Linking ISSN: 13899333 NLM ISO Abbreviation: Cell Tissue Bank Subsets: MEDLINE
أسماء مطبوعة: Original Publication: Dordrecht, the Netherlands : Kluwer Academic Publishers, c2000-
مواضيع طبية MeSH: Heart Valves* , Pulmonary Valve*, Young Adult ; Humans ; Transplantation, Homologous ; Tissue Donors ; Quality Control
مستخلص: More than 1000 donated aortic and pulmonary valves from predominantly European tissue banks were centrally decellularized and delivered to hospitals in Europe and Japan. Here, we report on the processing and quality controls before, during and after the decellularization of these allografts. Our experiences show that all tissue establishments, which provide native cardiovascular allografts for decellularization, meet comparably high-quality standards, regardless of their national origin. A total of 84% of all received allografts could be released as cell-free allografts. By far the most frequent reasons for rejection were non-release of the donor by the tissue establishment or severe contaminations of the native tissue donation. Only in 2% of all cases the specification for freedom from cells was not fulfilled, indicating that decellularization of human heart valves is a safe process with a very low discard ratio. In clinical use, cell-free cardiovascular allografts have been shown to be advantageous over conventional heart valve replacements, at least in young adults. These results open the discussion on the future gold standard and funding of this innovative therapeutic option for heart valve replacement.
(© 2023. The Author(s), under exclusive licence to Springer Nature B.V.)
References: Bobylev D, Horke A, Boethig D, Hazekamp M, Meyns B, Rega F, Dave H, Schmiady M, Ciubotaru A, Cheptanaru E, Vida V, Padalino M, Tsang V, Jashari R, Laufer G, Andreas M, Andreeva A, Tudorache I, Cebotari S, Haverich A, Sarikouch S (2022) 5-Year results from the prospective European multi-centre study on decellularized homografts for pulmonary valve replacement ESPOIR Trial and ESPOIR Registry data. Eur J Cardio-Thorac Surg. https://doi.org/10.1093/ejcts/ezac219. (PMID: 10.1093/ejcts/ezac219)
Coti I, Wenda S, Andreeva A, Kocher A, Laufer G, Fischer G, Andreas M (2020) Donor-specific HLA antibodies after fresh decellularized vs cryopreserved native allograft implantation. HLA 96(5):580–588. (PMID: 10.1111/tan.14077329753767702054)
Crapo P, Gilbert T, Badylak S (2011) An overview of tissue and whole organ decellularization processes. J Biomater 32(12):3233–3243. (PMID: 10.1016/j.biomaterials.2011.01.057)
Dekens E, Van Damme E, Jashari R, Van Hoeck B, Francois K, Bove T (2019) Durability of pulmonary homografts for reconstruction of the right ventricular outflow tract: how relevant are donor-related factors? Interact Cardiovasc Thorac Surg 28(4):503–509. (PMID: 10.1093/icvts/ivy31630476047)
Directive 2000/54/EC of the European Parliament and of the Council, Official Journal L 262, 17/10/2000, p. 21–45.
Directive 2004/23/EC of the European Parliament and of the Council, Official Journal L 102, 07/04/2004 P. 48–58.
Directive 2006/17/EC: Commission Directive (EU) 2006/17/EC, Official Journal of the European Union L38, 09/02/2006, p. 40–52.
Directive 2015/566: Commission Directive (EU) 2015/566, Official Journal of the European Union, L93/56, 09/04/2015, p. 56–68.
encepp.eu; retrieved 2022-09-06.
EP1881854, Bioartificial heart tissue graft and method for the production thereof, European Patent Agency.
EUPAS10201: Aortic Replacement using Individualised Regenerative Allografts: Bridging the Therapeutic Gap—ARISE.
EUPAS5064: European Clinical Study for the Application of Regenerative Heart Valves—ESPOIR.
Flameng W, Daenen W, Jashari R, Herijgers P, Meuris B (2015) Durability of homografts used to treat complex aortic valve endocarditis. Ann Thorac Surg 99(4):1234–1238. (PMID: 10.1016/j.athoracsur.2014.11.00225661581)
Goffin YA, Van Hoeck B, Jashari R, Soots K (2000) Banking of cryopreserved heart valves in Europe: assessment of a 10-year operation in the European Homograft Bank (EHB). J Heart Valve Dis 9(2):207–214. (PMID: 10772038)
Guide to the quality and safety of tissues and cells for human application. 4th Edition 2019, European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe.
Hopkins R (2006) From cadaver harvested homograft valves to tissue-engineered valve conduits. Prog Pediatr Cardiol 21:137–152. (PMID: 10.1016/j.ppedcard.2005.11.002)
Horke A, Bobylev D, Avsar M, Meyns B, Rega F, Hazekamp M et al (2020a) Paediatric aortic valve replacement using decellularized allografts. Eur J Cardiothorac Surg 58(4):817–824. (PMID: 10.1093/ejcts/ezaa119324431527890932)
Horke A, Tudorache I, Laufer G, Andreas M, Pomar JL, Pereda D, Quintana E, Sitges M, Meyns B, Rega F, Hazekamp M, Huebler M, Schmiady M, Pepper J, Rosendahl U, Lichtenberg A, Akhyari P, Jashari R, Boethig D, Bobylev D, Avsar M, Cebotari S, Haverich A, Sarikouch S (2020b) Early results from a prospective, single-arm European trial on decellularized allografts for aortic valve replacement: the ARISE study and ARISE Registry data. Eur J Cardiothorac Surg 58(5):1045–1053. (PMID: 10.1093/ejcts/ezaa100323864097577293)
https://www.pei.de/DE/arzneimittel/gewebezubereitungen/herzklappen/herzklappen-node.html ; retrieved 2022-09-05.
Jashari R (2021) Transplantation of cryopreserved human heart valves in Europe: 30 years of banking in Brussels and future perspectives. Cell Tissue Bank 22:519–537. (PMID: 10.1007/s10561-021-09902-2335329877853167)
Jashari R, Goffin Y, Vanderkelen A, Van Hoeck B, duVerger A, Fan Y, Holovska V, Brahy O (2010) European homograft bank: twenty years of cardiovascular tissue banking and collaboration with transplant coordination in Europe. Transpl Proc 42(1):183–189. (PMID: 10.1016/j.transproceed.2009.11.022)
Lichtenberg A, Cebotari S, Tudorache I, Sturz G, Winterhalter M, Hilfiker A, Haverich A (2006) Flow-dependent re-endothelialization of tissue-engineered heart valves. J Heart Valve Dis 15:287–294. (PMID: 16607913)
Meyns B, Jashari R, Gewillig M, Mertens L, Komárek A, Lesaffre E, Budts W, Daenen W (2005) Factors influencing the survival of cryopreserved homografts: the second homograft performs as well as the first. Eur J Cardiothorac Surg 28(2):211–216. (PMID: 10.1016/j.ejcts.2005.03.04115953733)
Moliner AM, Waligora J (2017) The European union policy in the field of rare diseases. Adv Exp Med Biol 1031:561–587. https://doi.org/10.1007/978-3-319-67144-4_30. (PMID: 10.1007/978-3-319-67144-4_3029214592)
Neumann A, Sarikouch S, Breymann T, Cebotari S, Boethig D, Horke A, Beerbaum P, Westhoff-Bleck M, Bertram H, Ono M, Tudorache I, Haverich A, Beutel G (2014) Early systemic cellular immune response in children and young adults receiving decellularized fresh allografts for pulmonary valve replacement. Tissue Eng Part A 20(5–6):1003–1011. (PMID: 10.1089/ten.tea.2013.0316241384703938920)
Ph. Eur. 2.6.1: European Pharmacopoeia 6.0, 01/2008:20601.
Ph. Eur. 2.6.12: European Pharmacopoeia 5.0, 01/2005:20612.
Shuler CO, Black GB, Jerrell JM (2013) Population-based treated prevalence of congenital heart disease in a pediatric cohort. Pediatr Cardiol 34(3):606–611. https://doi.org/10.1007/s00246-012-0505-3. (PMID: 10.1007/s00246-012-0505-322976198)
Solari S, Mastrobuoni S, De Kerchove L, Navarra E, Astarci P, Noirhomme P, Poncelet A, Jashari R, Rubay J, El Khoury G (2016) Over 20 years experience with aortic homograft in aortic valve replacement during acute infective endocarditis. Eur J Cardiothorac Surg 50(6):1158–1164. (PMID: 10.1093/ejcts/ezw17527229671)
Zahra S, Galea G, Jashari R, Perit P, deBy T (2019) Validation of microbiological testing in cardiovascular tissue establishments: results of a second international quality-round trial. Eur J Clin Microbiol Infect Dis 38:1481–1490. (PMID: 10.1007/s10096-019-03576-131081537)
فهرسة مساهمة: Keywords: Allograft; Cell-free; Decellularization; Heart valve; Human
تواريخ الأحداث: Date Created: 20230503 Date Completed: 20240229 Latest Revision: 20240229
رمز التحديث: 20240229
DOI: 10.1007/s10561-023-10092-2
PMID: 37138137
قاعدة البيانات: MEDLINE
الوصف
تدمد:1573-6814
DOI:10.1007/s10561-023-10092-2