{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T03:09:11Z","timestamp":1789096151821,"version":"build-2803163510"},"reference-count":16,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2025,1,30]],"date-time":"2025-01-30T00:00:00Z","timestamp":1738195200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Transplant."],"abstract":"<jats:p>More than a year after the Biological License Application (BLA) approval for CellTrans, cadaveric islet transplantation remains in demise in the United States (U.S.). While the therapy is unavailable to Americans, it is already a standard of care procedure in other countries, including Canada, Australia, and many in Europe. This article discusses the challenges stemming from an outdated regulatory framework in the U.S. concerning cadaveric islet transplantation. It also presents advocacy efforts by the transplant community for appropriate regulatory adjustments and discusses future perspectives.<\/jats:p>","DOI":"10.3389\/frtra.2025.1491568","type":"journal-article","created":{"date-parts":[[2025,1,30]],"date-time":"2025-01-30T11:55:28Z","timestamp":1738238128000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":3,"title":["Demise of cadaveric islet transplantation in the USA: Quo Vadis, 1 year after BLA approval and 24 years after the Edmonton breakthrough?"],"prefix":"10.3389","volume":"4","author":[{"given":"Piotr","family":"Witkowski","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicole","family":"Wojcik","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nathan","family":"Appelbaum","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John J.","family":"Fung","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rolf N.","family":"Barth","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Camillo","family":"Ricordi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2025,1,30]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"230","DOI":"10.1056\/NEJM200007273430401","article-title":"Islet transplantation in seven patients with type 1 diabetes mellitus using a glucocorticoid-free immunosuppressive regimen","volume":"343","author":"Shapiro","year":"2000","journal-title":"N Engl J Med"},{"key":"B2","doi-asserted-by":"publisher","first-page":"1365","DOI":"10.1111\/ajt.16397","article-title":"The demise of islet allotransplantation in the United States: a call for an urgent regulatory update","volume":"21","author":"Witkowski","year":"2021","journal-title":"Am J Transplant"},{"key":"B3","doi-asserted-by":"publisher","first-page":"519","DOI":"10.1016\/S2213-8587(22)00114-0","article-title":"Pancreatic islet transplantation in type 1 diabetes: 20-year experience from a single-centre cohort in Canada","volume":"10","author":"Marfil-Garza","year":"2022","journal-title":"Diabetes Endocrinol"},{"key":"B4","article-title":"Eleventh allograft report","year":""},{"key":"B5","doi-asserted-by":"publisher","first-page":"10507","DOI":"10.3389\/ti.2022.10507","article-title":"A worldwide survey of activities and practices in clinical islet of langerhans transplantation","volume":"35","author":"Berney","year":"2022","journal-title":"Transpl Int"},{"key":"B6","doi-asserted-by":"publisher","first-page":"2042","DOI":"10.2337\/dc19-0401","article-title":"Ten-year outcome of islet alone or islet after kidney transplantation in type 1 diabetes: a prospective parallel-arm cohort study","volume":"42","author":"Vantyghem","year":"2019","journal-title":"Diabetes Care"},{"key":"B7","doi-asserted-by":"publisher","first-page":"716","DOI":"10.1016\/S2213-8587(24)00241-9","article-title":"TREPID-ABM study group islet-after-kidney transplantation versus kidney alone in kidney transplant recipients with type 1 diabetes (KAIAK): a population-based target trial emulation in France","volume":"12","author":"Maanaoui","year":"2024","journal-title":"Lancet Diabetes Endocrinol"},{"key":"B8","doi-asserted-by":"publisher","first-page":"789526","DOI":"10.3389\/fendo.2021.789526","article-title":"Islets transplantation at a crossroads - need for urgent regulatory update in the United States: perspective presented during the scientific sessions 2021 at the American diabetes association congress","volume":"12","author":"Witkowski","year":"2022","journal-title":"Front Endocrinol"},{"key":"B9","doi-asserted-by":"publisher","first-page":"e409","DOI":"10.1097\/TP.0000000000003880","article-title":"Pancreatic islets quality and potency cannot be verified as required for drugs: reflection on the FDA review of a biological license application for human islets","volume":"105","author":"Witkowski","year":"2021","journal-title":"Transplantation"},{"key":"B10","doi-asserted-by":"publisher","first-page":"2620","DOI":"10.1111\/ajt.16555","article-title":"Regulatory updates are needed to prevent the commercialization of islet transplantation in the United States","volume":"21","author":"Witkowski","year":"2021","journal-title":"Am J Transplant"},{"key":"B11","doi-asserted-by":"publisher","first-page":"2878","DOI":"10.3390\/jcm10132878","article-title":"Arguments against the requirement of a biological license application for human pancreatic islets: the position statement of the islets for US collaborative presented during the FDA advisory committee meeting","volume":"10","author":"Witkowski","year":"2021","journal-title":"J Clin Med"},{"key":"B12","doi-asserted-by":"publisher","first-page":"1177","DOI":"10.1111\/tri.13931","article-title":"Islet transplantation in the United States \u2013 Quo Vadis? 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