{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,13]],"date-time":"2025-10-13T15:35:05Z","timestamp":1760369705488},"reference-count":29,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2021,4,1]],"date-time":"2021-04-01T00:00:00Z","timestamp":1617235200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2021,4,1]],"date-time":"2021-04-01T00:00:00Z","timestamp":1617235200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Universit\u00e4tsklinik M\u00fcnchen"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Med Ethics"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>The transplantation of porcine islet cells provides a new potential therapy to treat patients with type 1 diabetes mellitus (T1DM). Compared to other biomedical technologies, xenotransplantation stands out in terms of its involvement of animals as graft sources, as well as the possible transmission of infectious diseases. As these aspects are especially relevant for potential xenotransplantation recipients, it is important to assess their opinion regarding this technology, in particular in terms of the requirements that should be met in the informed consent process for xenotransplantation.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We conducted qualitative interviews with seven T1DM patients to assess their information needs prior to xenotransplantation. Before the interview, the participants received a model informed consent form for a clinical trial with porcine islet cells transplantation. The interviews were transcribed and analysed using qualitative content analysis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In the interviews, we identified several requirements that are crucial for patients with T1DM in order to consider xenotransplantation as a potential treatment option: therapy-related requirements, professional care and supervision, successful behaviour and attitude management, improving quality of life, and managing control\/self-determination challenges. Regarding the informed consent form, several of the participants\u2019 questions remained open and should be addressed in more detail. The interviewees stressed the importance of personal consultations.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>To become a sustainable therapeutic option, patients especially expected an improved diabetes control and a reduction of diabetes-related burdens. Health-related aspects prove to be pivotal for diabetic patients when considering porcine islet cell transplantation. The use of pigs as source for organ retrievals was not considered as problematic.<\/jats:p><\/jats:sec>","DOI":"10.1186\/s12910-021-00607-5","type":"journal-article","created":{"date-parts":[[2021,4,1]],"date-time":"2021-04-01T09:03:19Z","timestamp":1617267799000},"update-policy":"http:\/\/dx.doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["What does it take to consent to islet cell xenotransplantation?: Insights from an interview study with type 1 diabetes patients and review of the literature"],"prefix":"10.1186","volume":"22","author":[{"given":"Johannes","family":"K\u00f6gel","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sandra","family":"Thiersch","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Barbara","family":"Ludwig","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jochen","family":"Seissler","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Georg","family":"Marckmann","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2021,4,1]]},"reference":[{"key":"607_CR1","doi-asserted-by":"publisher","first-page":"141","DOI":"10.1038\/nm0298-141","volume":"4","author":"FH Bach","year":"1998","unstructured":"Bach FH, Fishman JA, Daniels N, Proimos J, Anderson B, Carpenter CB, et al. Uncertainty in xenotransplantation: individual benefit versus collective risk. Nat Med. 1998;4:141\u20134.","journal-title":"Nat Med"},{"key":"607_CR2","doi-asserted-by":"publisher","first-page":"53","DOI":"10.1023\/A:1009972928996","volume":"4","author":"JH Barker","year":"2001","unstructured":"Barker JH, Polcrack L. Respect for persons, informed consent and the assessment of infectious disease risks in xenotransplantation. Med Health Care Philos. 2001;4:53\u201370.","journal-title":"Med Health Care Philos"},{"issue":"3","key":"607_CR3","doi-asserted-by":"publisher","first-page":"119","DOI":"10.1111\/j.1471-8847.2009.00251.x","volume":"9","author":"R Sparrow","year":"2009","unstructured":"Sparrow R. Xenotransplantation, consent and international justice. 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EMBO Rep. 2020;21(9):e50274. https:\/\/doi.org\/10.15252\/embr.202050274.","journal-title":"EMBO Rep"}],"container-title":["BMC Medical Ethics"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s12910-021-00607-5.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/article\/10.1186\/s12910-021-00607-5\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s12910-021-00607-5.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,8,27]],"date-time":"2024-08-27T08:45:37Z","timestamp":1724748337000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmcmedethics.biomedcentral.com\/articles\/10.1186\/s12910-021-00607-5"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,4,1]]},"references-count":29,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2021,12]]}},"alternative-id":["607"],"URL":"https:\/\/doi.org\/10.1186\/s12910-021-00607-5","relation":{},"ISSN":["1472-6939"],"issn-type":[{"type":"electronic","value":"1472-6939"}],"subject":[],"published":{"date-parts":[[2021,4,1]]},"assertion":[{"value":"28 December 2020","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"23 March 2021","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"1 April 2021","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"All methods included in the interview study were carried out in accordance with the Declaration of Helsinki. The study has been approved by the Ethics Committee of the Medical Faculty of the LMU Munich (Number: 017-12). Written informed consent was obtained from the participants for publication of their cases and any accompanying tables. A copy of the written consent is available for review by the editor of this journal.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"JK, ST, BL, JS and GM declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"37"}}