TransplantationPub Date : 2024-10-23DOI: 10.1097/TP.0000000000005181
Esteban Cortes Garcia, Alessia Giarraputo, Maud Racapé, Valentin Goutaudier, Cindy Ursule-Dufait, Pierre de la Grange, Franck Letourneur, Marc Raynaud, Clément Couderau, Fariza Mezine, Jessie Dagobert, Oriol Bestard, Francesc Moreso, Jean Villard, Fabian Halleck, Magali Giral, Sophie Brouard, Richard Danger, Pierre-Antoine Gourraud, Marion Rabant, Lionel Couzi, Moglie Le Quintrec, Nassim Kamar, Emmanuel Morelon, François Vrtovsnik, Jean-Luc Taupin, Renaud Snanoudj, Christophe Legendre, Dany Anglicheau, Klemens Budde, Carmen Lefaucheur, Alexandre Loupy, Olivier Aubert
{"title":"Archetypal Analysis of Kidney Allograft Biopsies Using Next-generation Sequencing Technology.","authors":"Esteban Cortes Garcia, Alessia Giarraputo, Maud Racapé, Valentin Goutaudier, Cindy Ursule-Dufait, Pierre de la Grange, Franck Letourneur, Marc Raynaud, Clément Couderau, Fariza Mezine, Jessie Dagobert, Oriol Bestard, Francesc Moreso, Jean Villard, Fabian Halleck, Magali Giral, Sophie Brouard, Richard Danger, Pierre-Antoine Gourraud, Marion Rabant, Lionel Couzi, Moglie Le Quintrec, Nassim Kamar, Emmanuel Morelon, François Vrtovsnik, Jean-Luc Taupin, Renaud Snanoudj, Christophe Legendre, Dany Anglicheau, Klemens Budde, Carmen Lefaucheur, Alexandre Loupy, Olivier Aubert","doi":"10.1097/TP.0000000000005181","DOIUrl":"https://doi.org/10.1097/TP.0000000000005181","url":null,"abstract":"<p><strong>Background: </strong>In kidney transplantation, molecular diagnostics may be a valuable approach to improve the precision of the diagnosis. Using next-generation sequencing (NGS), we aimed to identify clinically relevant archetypes.</p><p><strong>Methods: </strong>We conducted an Illumina bulk RNA sequencing on 770 kidney biopsies (540 kidney recipients) collected between 2006 and 2021 from 11 European centers. Differentially expressed genes were determined for 11 Banff lesions. An ElasticNet model was used for feature selection, and 4 machine learning classifiers were trained to predict the probability of presence of the lesions. NGS-based classifiers were used in an unsupervised archetypal analysis to different archetypes. The association of the archetypes with allograft survival was assessed using the iBox risk prediction score.</p><p><strong>Results: </strong>The ElasticNet feature selection reduced the number of the genes from a range of 859-10 830 to a range of 52-867 genes. NGS-based classifiers demonstrated robust performances (precision-recall area under the curves 0.708-0.980) in predicting the Banff lesions. Archetypal analysis revealed 8 distinct phenotypes, each characterized by distinct clinical, immunological, and histological features. Although the archetypes confirmed the well-defined Banff rejection phenotypes for T cell-mediated rejection and antibody-mediated rejection, equivocal histologic antibody-mediated rejection, and borderline diagnoses were reclassified into different archetypes based on their molecular signatures. The 8 NGS-based archetypes displayed distinct allograft survival profiles with incremental graft loss rates between archetypes, ranging from 90% to 56% rates 7 y after evaluation (P < 0.0001).</p><p><strong>Conclusions: </strong>Using molecular phenotyping, 8 archetypes were identified. These NGS-based archetypes might improve disease characterization, reclassify ambiguous Banff diagnoses, and enable patient-specific risk stratification.</p>","PeriodicalId":23316,"journal":{"name":"Transplantation","volume":null,"pages":null},"PeriodicalIF":5.3,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142508767","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
TransplantationPub Date : 2024-10-23DOI: 10.1097/TP.0000000000005231
Hyun-Jun Nam, Deok-Gie Kim, Eun-Ki Min, Jae Geun Lee, Dai Hoon Han, Sinyoung Kim, Kyung-A Lee, Gi Hong Choi, Dong Jin Joo, Hyun Ok Kim, Soon Sung Kwon, Myoung Soo Kim
{"title":"Preoperative Factors Affecting Graft Survival After ABO-incompatible Adult Liver Transplantation.","authors":"Hyun-Jun Nam, Deok-Gie Kim, Eun-Ki Min, Jae Geun Lee, Dai Hoon Han, Sinyoung Kim, Kyung-A Lee, Gi Hong Choi, Dong Jin Joo, Hyun Ok Kim, Soon Sung Kwon, Myoung Soo Kim","doi":"10.1097/TP.0000000000005231","DOIUrl":"https://doi.org/10.1097/TP.0000000000005231","url":null,"abstract":"<p><strong>Background: </strong>Although ABO-incompatible liver transplantation (ABOi LT) has undergone remarkable progress, the prognostic factors are poorly understood. This study aimed to elucidate the preoperative factors affecting graft survival after ABOi LT.</p><p><strong>Methods: </strong>Patients who underwent ABOi LT between January 2012 and December 2020 at a single institution in South Korea were retrospectively reviewed. A total of 146 recipients, including 34 patients with graft loss, were analyzed.</p><p><strong>Results: </strong>In the multivariate Cox proportional hazard model, recipient age (≥55 y; hazard ratio, 2.47; 95% confidence interval, 1.18-5.19; P = 0.017) and donor ABO type (donor A, hazard ratio, 3.12; 95% confidence interval, 1.33-7.33; P = 0.009) were significantly associated with an increased risk of graft loss. The most common cause of graft loss was recipient death due to bacterial infection (15/34, 44.1%). Both recipient age and donor ABO type were associated with an increased risk of recipient death due to bacterial infections. The incidence of complications after ABOi LT, including antibody-mediated rejection and diffuse intrahepatic biliary stricture, did not differ according to recipient age or donor ABO type.</p><p><strong>Conclusions: </strong>These findings suggest that recipient age and donor ABO type should be considered when preparing for ABOi LT. Careful monitoring and care after transplantation are required for recipients with preoperative risk factors.</p>","PeriodicalId":23316,"journal":{"name":"Transplantation","volume":null,"pages":null},"PeriodicalIF":5.3,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142508773","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
TransplantationPub Date : 2024-10-23DOI: 10.1097/TP.0000000000005233
Ahmer M Hameed, Zane Wang, Peter Yoon, Farzaneh Boroumand, Animesh Singla, Paul Roberston, Renan Gaspi, Chris Zhang, Jerome Laurence, Christopher Nahm, Jinna Yao, Lawrence Yuen, Taina Lee, Armando Teixeira-Pinto, Wayne J Hawthorne, Natasha M Rogers, Germaine Wong, Henry C Pleass
{"title":"Normothermic Ex Vivo Perfusion Before Transplantation of the Kidney (NEXT-Kidney): A Single-center, Nonrandomized Feasibility Study.","authors":"Ahmer M Hameed, Zane Wang, Peter Yoon, Farzaneh Boroumand, Animesh Singla, Paul Roberston, Renan Gaspi, Chris Zhang, Jerome Laurence, Christopher Nahm, Jinna Yao, Lawrence Yuen, Taina Lee, Armando Teixeira-Pinto, Wayne J Hawthorne, Natasha M Rogers, Germaine Wong, Henry C Pleass","doi":"10.1097/TP.0000000000005233","DOIUrl":"https://doi.org/10.1097/TP.0000000000005233","url":null,"abstract":"<p><strong>Background: </strong>There is conflicting evidence regarding the efficacy of normothermic machine perfusion (NMP) in suboptimal deceased donor kidneys. We aimed to assess the feasibility and short-term efficacy of brief preimplantation NMP in circulatory death (DCD) kidneys.</p><p><strong>Methods: </strong>In this nonrandomized, single-center, prospective clinical trial, DCD kidneys underwent 1 to 3 h of NMP before implantation, aiming to achieve short ischemic times off NMP. The primary outcomes included feasibility and safety. Secondary outcomes included efficacy outcomes (delayed graft function and estimated glomerular filtration rate (eGFR) at 1, 6, and 12 mo), which were compared with the contralateral kidney that did not receive NMP.</p><p><strong>Results: </strong>Eighteen DCD kidneys underwent NMP between 2020 and 2022, with at least 1 h completed in 16 (88.9%) of these kidneys (median 1 h); one kidney was removed after 5 min because of cannula failure and another at 54 min because of a sudden drop in blood flows. There was no episode of graft loss on the machine or postoperative vascular thromboses. All 18 kidneys were transplanted, with no cases of PNF or graft loss at 12 mo. Seventeen of the contralateral CS kidneys were transplanted. Compared with the contralateral kidneys, a lower incidence of delayed graft function (23.5% versus 64.7%; P = 0.046) was observed. There were no differences in the eGFR slopes between the two groups over time (P = 0.254).</p><p><strong>Conclusions: </strong>NMP is safe, feasible and efficacious in the Australian setting, with this relatively small cohort demonstrating good early outcomes compared to CS alone in our study of DCD kidneys.</p>","PeriodicalId":23316,"journal":{"name":"Transplantation","volume":null,"pages":null},"PeriodicalIF":5.3,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142508771","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
TransplantationPub Date : 2024-10-22DOI: 10.1097/TP.0000000000005212
Dominique E Martin, Alexander M Capron, Riadh A S Fadhil, John L R Forsythe, Benita Padilla, Alicia Pérez-Blanco, Kristof Van Assche, Milka Bengochea, Lilia Cervantes, Anna Forsberg, Noble Gracious, Marisa R Herson, Rümeyza Kazancioğlu, Thomas Müller, Luc Noël, Esteve Trias, Marta López-Fraga
{"title":"Prevention of Trafficking in Organs, Tissues, and Cells.","authors":"Dominique E Martin, Alexander M Capron, Riadh A S Fadhil, John L R Forsythe, Benita Padilla, Alicia Pérez-Blanco, Kristof Van Assche, Milka Bengochea, Lilia Cervantes, Anna Forsberg, Noble Gracious, Marisa R Herson, Rümeyza Kazancioğlu, Thomas Müller, Luc Noël, Esteve Trias, Marta López-Fraga","doi":"10.1097/TP.0000000000005212","DOIUrl":"https://doi.org/10.1097/TP.0000000000005212","url":null,"abstract":"<p><p>Trafficking in human organs, cells, and tissues has long been a source of concern for health authorities and professionals, and several international ethical guidance documents and national laws have affirmed the prohibition of trade in these substances of human origin (SoHOs). However, despite considerable attention to the issue of organ trafficking, this remains a substantial and widespread problem internationally. In contrast, trafficking in cells, tissues, and medical products derived from SoHOs has received comparatively little attention, and the extent and nature of such trafficking remain largely unknown. Consequently, as part of the 2023 Global Summit on Convergence in Transplantation held in Santander, Spain, an ethics working group was assigned the task of formulating actionable recommendations to support the prevention of trafficking in all SoHOs. In reporting on this work, we review factors that may influence the persistent trafficking of SoHOs, explore the potential difficulties associated with the collection and reporting of data about suspected trafficking activities, and argue that more practical and consistent guidance, training, and regulatory frameworks are needed internationally to support effective reporting, sharing of data, and collaborative responses to suspected trafficking cases. We also discuss the importance of psychosocial evaluation of living donors as a strategy to detect and prevent organ trafficking and strive to advance the implementation of this well-established recommendation by outlining minimum standards for psychosocial evaluation of living donors.</p>","PeriodicalId":23316,"journal":{"name":"Transplantation","volume":null,"pages":null},"PeriodicalIF":5.3,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142508774","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
TransplantationPub Date : 2024-10-22DOI: 10.1097/TP.0000000000005222
Beatriz Domínguez-Gil, Marta López-Fraga, Elmi Muller, Luciano Potena, Dominique E Martin, Alicia Pérez Blanco, Kristof Van Assche, Gabriel C Oniscu, Efstratios Chatzixiros, Vivekanand Jha, Eduardo Miñambres, Natividad Cuende, John L R Forsythe, Dale Gardiner, Sanjay Nagral, Stefan G Tullius, Matthew Cooper, Francis L Delmonico
{"title":"Santander Global Summit in Transplantation: Supporting Global Convergence in the Shared Goals of Sufficiency, Transparency, and Oversight.","authors":"Beatriz Domínguez-Gil, Marta López-Fraga, Elmi Muller, Luciano Potena, Dominique E Martin, Alicia Pérez Blanco, Kristof Van Assche, Gabriel C Oniscu, Efstratios Chatzixiros, Vivekanand Jha, Eduardo Miñambres, Natividad Cuende, John L R Forsythe, Dale Gardiner, Sanjay Nagral, Stefan G Tullius, Matthew Cooper, Francis L Delmonico","doi":"10.1097/TP.0000000000005222","DOIUrl":"https://doi.org/10.1097/TP.0000000000005222","url":null,"abstract":"","PeriodicalId":23316,"journal":{"name":"Transplantation","volume":null,"pages":null},"PeriodicalIF":5.3,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142508778","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
TransplantationPub Date : 2024-10-22DOI: 10.1097/TP.0000000000005234
Dale Gardiner, Andrew McGee, Ali Abdul Kareem Al Obaidli, Matthew Cooper, Krista L Lentine, Eduardo Miñambres, Sanjay Nagral, Helen Opdam, Francesco Procaccio, Sam D Shemie, Michael Spiro, Martín Torres, David Thomson, Amy D Waterman, Beatriz Domínguez-Gil, Francis L Delmonico
{"title":"Developing and Expanding Deceased Organ Donation to its Maximum Therapeutic Potential: An Actionable Global Challenge From the 2023 Santander Summit.","authors":"Dale Gardiner, Andrew McGee, Ali Abdul Kareem Al Obaidli, Matthew Cooper, Krista L Lentine, Eduardo Miñambres, Sanjay Nagral, Helen Opdam, Francesco Procaccio, Sam D Shemie, Michael Spiro, Martín Torres, David Thomson, Amy D Waterman, Beatriz Domínguez-Gil, Francis L Delmonico","doi":"10.1097/TP.0000000000005234","DOIUrl":"https://doi.org/10.1097/TP.0000000000005234","url":null,"abstract":"<p><p>On November 9 and 10, 2023, the Organización Nacional de Trasplantes (ONT), under the Spanish Presidency of the Council of the European Union, convened in Santander a Global Summit entitled \"Towards Global Convergence in Transplantation: Sufficiency, Transparency and Oversight.\" This article summarizes two distinct but related challenges elaborated at the Santander Summit by Working Group 2 that must be overcome if we are to develop and expand deceased donation worldwide and achieve the goal of self-sufficiency in organ donation and transplantation. Challenge 1: the need for a unified concept of death based on the permanent cessation of brain function. Working group 2 proposed that challenge 1 requires the global community to work toward a uniform, worldwide definition of human death, conceptually unifying circulatory and neurological criteria of death around the cessation of brain function and accepting that permanent cessation of brain function is a valid criterion to determine death. Challenge 2: reducing disparities in deceased donation and increasing organ utilization through donation after the circulatory determination of death (DCDD). Working group 2 proposed that challenge 2 requires the global community to work toward increasing organ utilization through DCDD, expanding DCDD through in situ normothermic regional perfusion, and expanding DCDD through ex situ machine organ perfusion technology. Recommendations for implementation are described.</p>","PeriodicalId":23316,"journal":{"name":"Transplantation","volume":null,"pages":null},"PeriodicalIF":5.3,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142508768","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
TransplantationPub Date : 2024-10-22DOI: 10.1097/TP.0000000000005182
Elmi Muller, Beatriz Dominguez-Gil, Curie Ahn, Marina Berenguer, Massimo Cardillo, Efstratios Chatzixiros, Paolo Cortesi, Marisa Herson, Andre Ilbawi, Vivekanand Jha, Beatriz Mahillo, Derek M Manas, Alejandro Nino-Murcia, Faissal A M Shaheen, Peter Stock, Luciano Potena
{"title":"Transplantation: A Priority in the Healthcare Agenda.","authors":"Elmi Muller, Beatriz Dominguez-Gil, Curie Ahn, Marina Berenguer, Massimo Cardillo, Efstratios Chatzixiros, Paolo Cortesi, Marisa Herson, Andre Ilbawi, Vivekanand Jha, Beatriz Mahillo, Derek M Manas, Alejandro Nino-Murcia, Faissal A M Shaheen, Peter Stock, Luciano Potena","doi":"10.1097/TP.0000000000005182","DOIUrl":"https://doi.org/10.1097/TP.0000000000005182","url":null,"abstract":"<p><strong>Background: </strong>In November 2023, in the context of the Spanish Presidency of the Council of the European Union, the Organization National de Transplante organized a global summit discussing global action in transplantation for the next decade. This article reports the recommendations supporting the need to prioritize transplantation in healthcare systems.</p><p><strong>Methods: </strong>The working group investigated how transplantation addresses noncommunicable disease mortality, particularly related to kidney and liver disease. They also investigated how transplantation can contribute to the achievement of several of the United Nations Sustainable Development Goals, especially Goal 3 (good health and well-being), Goal 8 (sustained, inclusive, and sustainable economic growth and employment for all), and Goal 13 (combat climate change and its impact).</p><p><strong>Results: </strong>By prioritizing transplantation, the increased availability and accessibility of life-saving organs and tissues to the public will not only lead to saving more lives and improving health outcomes for individual patients but also contribute to the development of a resilient health system in general in that country as a consequence of developing the infrastructure required for transplantation.</p><p><strong>Conclusions: </strong>The ethical principles associated with transplantation promote the principles of solidarity in society by fostering the donation process and equity in access to therapy. This article aims to advocate for the widespread availability of solid organ, tissue, and cell transplantation for all patients.</p>","PeriodicalId":23316,"journal":{"name":"Transplantation","volume":null,"pages":null},"PeriodicalIF":5.3,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142508783","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
TransplantationPub Date : 2024-10-22DOI: 10.1097/TP.0000000000005106
Dominique E Martin, Kristof Van Assche, Lilia Cervantes, John L R Forsythe, Thomas Muller, Alicia Perez-Blanco, Esteve Trias, Milka Bengochea, Alexander M Capron, Riadh A S Fadhil, Anna Forsberg, Noble Gracious, Marisa R Herson, Rumeyza Kazancioğlu, Luc Noel, Benita Padilla, Marta Lopez-Fraga
{"title":"Toward Equity in Global Access to SoHO-based Therapies: Recommendations for Action.","authors":"Dominique E Martin, Kristof Van Assche, Lilia Cervantes, John L R Forsythe, Thomas Muller, Alicia Perez-Blanco, Esteve Trias, Milka Bengochea, Alexander M Capron, Riadh A S Fadhil, Anna Forsberg, Noble Gracious, Marisa R Herson, Rumeyza Kazancioğlu, Luc Noel, Benita Padilla, Marta Lopez-Fraga","doi":"10.1097/TP.0000000000005106","DOIUrl":"https://doi.org/10.1097/TP.0000000000005106","url":null,"abstract":"<p><p>Therapies derived from substances of human origin (SoHOs) such as organs, cells, and tissues provide life-saving or life-changing treatment for millions of people worldwide each year. However, many people lack timely access to SoHO-based therapies because of insufficient supplies of these exceptional health resources and/or broader barriers in access to healthcare. Despite well-established governmental commitments to promote health equity in general and equity of access to SoHOs in particular, information about inequities in access to most SoHO-based therapies is scarce. Furthermore, the issue of equitable allocation of SoHO-based therapies has received little attention from policymakers and ethicists, except in the context of organ allocation for transplantation. Consequently, the extent and nature of potential inequities within and between countries are largely unknown, and few sources of guidance are available to support progress toward equity in global access to SoHO-based therapies. We present here the findings of an international ethics working group convened in preparation for the 2023 Global Summit on Convergence in Transplantation, organized in Santander, Spain. The group sought to assess potential gaps in knowledge about inequities involving SoHO-based therapies, to elucidate systemic factors that may influence access to these therapies, and to consider how policies and frameworks governing access to and allocation of SoHO-based therapies may promote equity when it is necessary to define boundaries in access because of insufficiency of supply. In discussing these challenges, we also outline several recommendations for action by governments and health authorities.</p>","PeriodicalId":23316,"journal":{"name":"Transplantation","volume":null,"pages":null},"PeriodicalIF":5.3,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142508782","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
TransplantationPub Date : 2024-10-22DOI: 10.1097/TP.0000000000005169
Natividad Cuende, Stefan G Tullius, Ander Izeta, Verena Plattner, Martin Börgel, Rachele Ciccocioppo, Rafael Correa-Rocha, Mickey B C Koh, Vincenzo De Angelis, Gabriel E Gondolesi, Renske Ten Ham, Robert J Porte, Dolores Hernández-Maraver, Wayne J Hawthorne, Anna Sureda, Giuseppe Orlando, Börje Haraldsson, Nancy L Ascher, Beatriz Dominguez-Gil, Gabriel C Oniscu
{"title":"Promoting Equitable and Affordable Patient Access to Safe and Effective Innovations in Donation and Transplantation of Substances of Human Origin and Derived Therapies.","authors":"Natividad Cuende, Stefan G Tullius, Ander Izeta, Verena Plattner, Martin Börgel, Rachele Ciccocioppo, Rafael Correa-Rocha, Mickey B C Koh, Vincenzo De Angelis, Gabriel E Gondolesi, Renske Ten Ham, Robert J Porte, Dolores Hernández-Maraver, Wayne J Hawthorne, Anna Sureda, Giuseppe Orlando, Börje Haraldsson, Nancy L Ascher, Beatriz Dominguez-Gil, Gabriel C Oniscu","doi":"10.1097/TP.0000000000005169","DOIUrl":"https://doi.org/10.1097/TP.0000000000005169","url":null,"abstract":"<p><p>Innovation is a hallmark of organ, tissue, and cell transplantation. The development of new treatments derived from these substances of human origin (SoHO) has rapidly evolved in recent years. Despite the great benefits that these innovative therapies could bring to patients, significant difficulties have arisen in making them equitably and widely accessible. Herein, we identify and address 4 challenges to promote innovation in this field in a collaborative, sustainable, and transparent manner and propose some concrete solutions applicable to SoHO-derived treatments, ranging from cell therapies to solid organ transplantation. Regulators, health policymakers, and government officials are recommended to incorporate specific elements into the regulatory frameworks of their respective jurisdictions, although regulatory convergence and equivalent quality and safety standards applicable to SoHO at a global level would be needed. An innovation-driven regulatory environment, respectful with the human origin and in accordance with the altruistic donation of SoHO, should be encouraged to improve the safety, effectiveness, accessibility, and affordability of SoHO and to promote collaboration between countries and between public and private sectors. This overview is the outcome of a working group focused on \"Innovation in the donation and clinical application of SoHO\" as part of the international Summit \"Towards Global Convergence in Transplantation: Sufficiency, Transparency and Oversight\" convened by the Organización Nacional de Trasplantes under the Spanish Presidency of the Council of the European Union in November 2023 and cosponsored by the Council of Europe, the World Health Organization, the Transplantation Society, and the European Society for Organ Transplantation.</p>","PeriodicalId":23316,"journal":{"name":"Transplantation","volume":null,"pages":null},"PeriodicalIF":5.3,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142508775","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
TransplantationPub Date : 2024-10-22DOI: 10.1097/TP.0000000000005110
Michael Spiro, Dimitri A Raptis, Krista L Lentine, Matthew Cooper, Amy D Waterman, Gabriel C Oniscu, Helen I Opdam, S Joseph Kim, Francesco Procaccio, Sanjay Nagral, Dale Gardiner, Mohamed Rela, Beatriz Dominguez-Gil, Francis L Delmonico
{"title":"Reinforcing Global Oversight of Organ Transplantation: Activity and Outcome Monitoring Through the Development of Registries.","authors":"Michael Spiro, Dimitri A Raptis, Krista L Lentine, Matthew Cooper, Amy D Waterman, Gabriel C Oniscu, Helen I Opdam, S Joseph Kim, Francesco Procaccio, Sanjay Nagral, Dale Gardiner, Mohamed Rela, Beatriz Dominguez-Gil, Francis L Delmonico","doi":"10.1097/TP.0000000000005110","DOIUrl":"https://doi.org/10.1097/TP.0000000000005110","url":null,"abstract":"<p><p>Establishing transparency and oversight of organ transplantation by regulatory agencies is of paramount importance to assure ethical, legal, and clinically robust transplantation practices. Registries reporting activity and outcome data of the donor and recipient, including donor source (living or deceased), must be developed for each transplant and should be a mandatory requirement to achieve accreditation to perform transplant surgeries. Collected data for the living organ donor must include the nationality, the nature of their relationship with the recipient, and the complications encountered by living donors that result in prolonged morbidity or mortality. Long-term patient and graft survival must be reported for the recipient with the underlying reasons for mortality or graft loss. To retain the authorization to perform organ transplantation, a facility must ensure that it reports this required information regarding every organ transplant.</p>","PeriodicalId":23316,"journal":{"name":"Transplantation","volume":null,"pages":null},"PeriodicalIF":5.3,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142508777","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}