دورية أكاديمية

The Demise of Islet Allotransplantation in the US: A Call for an Urgent Regulatory Update The 'ISLETS FOR US' Collaborative

التفاصيل البيبلوغرافية
العنوان: The Demise of Islet Allotransplantation in the US: A Call for an Urgent Regulatory Update The 'ISLETS FOR US' Collaborative
المؤلفون: Witkowski, Piotr, Philipson, Louis, Kaufman, Dixon B, Ratner, Lloyd, Abouljoud, Marwan S, Bellin, Melena, Buse, John, Kandeel, Fouad, Stock, Peter, Mulligan, David, Markmann, James F, Kozlowski, Tomasz, Andreoni, Kenneth, Alejandro, Rodolfo, Baidal, David, Hardy, Mark A, Wickrema, Amittha, Mirmira, Raghavendra G, Fung, John, Becker, Yolanda, Josephson, Michelle A, Bachul, Piotr J, Pyda, Jordan S, Charlton, Michael, Millis, J. Michael, Gaglia, Jason, Stratta, Robert J, Fridell, Jonathan A, Niederhaus, Silke, Forbes, Rachael C, Jayant, Kumar, Robertson, R. Paul, Odorico, Jon, Levy, Marlon, Harland, Robert, Abrams, Peter L, Olaitan, Oyedolamu K, Kandaswamy, Raja, Wellen, Jason, Japour, Anthony J, Desai, Chirag S, Naziruddin, Bashoo, Balamurugan, Appakalai N, Barth, Rolf N, Ricordi, Camillo
المصدر: Surgery Articles
بيانات النشر: Henry Ford Health Scholarly Commons
سنة النشر: 2020
المجموعة: Henry Ford Health System Scholarly Commons
مصطلحات موضوعية: Transplant and Abdominal Surgery
الوصف: Islet allotransplantation in the United States (US) is facing an imminent demise. Despite nearly three decades of progress in the field, an archaic regulatory framework has stymied US clinical practice. Current regulations do not reflect the state-of-the-art in clinical or technical practices. In the US, islets are considered biologic drugs and "more than minimally manipulated" human cell and tissue products (HCT/Ps). Across the world, human islets are appropriately defined as "minimally manipulated tissue" which has led to islet transplantation becoming a standard-of-care procedure for patients with type 1 diabetes mellitus and problematic hypoglycemia. As a result of the outdated US regulations, only eleven patients underwent allo-ITx in the US between 2011-2016 and all in the setting of a clinical trial. Herein, we describe the current regulations pertaining to islet transplantation in the United States. We explore the progress which has been made in the field and demonstrate why the regulatory framework must be updated to both, better reflect our current clinical practice and to deal with upcoming challenges. We propose specific updates to current regulations which are required for the renaissance of ethical, safe, effective, and affordable allo-ITx in the United States.
نوع الوثيقة: text
وصف الملف: application/pdf
اللغة: unknown
العلاقة: https://scholarlycommons.henryford.com/surgery_articles/455Test; https://scholarlycommons.henryford.com/context/surgery_articles/article/1455/viewcontent/ajt.16397.pdfTest
الإتاحة: https://scholarlycommons.henryford.com/surgery_articles/455Test
https://scholarlycommons.henryford.com/context/surgery_articles/article/1455/viewcontent/ajt.16397.pdfTest
رقم الانضمام: edsbas.98AEC361
قاعدة البيانات: BASE