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The demise of islet allotransplantation in the United States: A call for an urgent regulatory update.
Witkowski, Piotr; Philipson, Louis H; Kaufman, Dixon B; Ratner, Lloyd E; Abouljoud, Marwan S; Bellin, Melena D; Buse, John B; Kandeel, Fouad; Stock, Peter G; Mulligan, David C; Markmann, James F; Kozlowski, Tomasz; Andreoni, Kenneth A; Alejandro, Rodolfo; Baidal, David A; Hardy, Mark A; Wickrema, Amittha; Mirmira, Raghavendra G; Fung, John; Becker, Yolanda T; Josephson, Michelle A; Bachul, Piotr J; Pyda, Jordan S; Charlton, Michael; Millis, J Michael; Gaglia, Jason L; Stratta, Robert J; Fridell, Jonathan A; Niederhaus, Silke V; Forbes, Rachael C; Jayant, Kumar; Robertson, R Paul; Odorico, Jon S; Levy, Marlon F; Harland, Robert C; Abrams, Peter L; Olaitan, Oyedolamu K; Kandaswamy, Raja; Wellen, Jason R; Japour, Anthony J; Desai, Chirag S; Naziruddin, Bashoo; Balamurugan, Appakalai N; Barth, Rolf N; Ricordi, Camillo.
Afiliación
  • Witkowski P; Department of Surgery, Transplantation Institute, University of Chicago, Chicago, Illinois, USA.
  • Philipson LH; Kovler Diabetes Center, University of Chicago, Chicago, Illinois, USA.
  • Kaufman DB; Division of Transplantation, Department of Surgery, University of Wisconsin, School of Medicine and Public Health, Madison, Wisconsin, USA.
  • Ratner LE; Department of Surgery, Columbia University College of Physicians and Surgeons, New York, New York, USA.
  • Abouljoud MS; Transplant and Hepatobiliary Surgery, Henry Ford Hospital, Detroit, Michigan, USA.
  • Bellin MD; Schulze Diabetes Institute, Department of Surgery, University of Minnesota, Minneapolis, Minnesota, USA.
  • Buse JB; Division of Endocrinology, Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.
  • Kandeel F; Department of Translational Research and Cellular Therapeutics, Diabetes and Metabolism Research Institute, Beckman Research Institute of City of Hope, Duarte, California, USA.
  • Stock PG; Division of Transplant Surgery, Department of Surgery, University of California, San Francisco, California, USA.
  • Mulligan DC; Department of Surgery, Transplantation and Immunology, Yale University, New Haven, Connecticut, USA.
  • Markmann JF; Division of Transplantation, Department of Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
  • Kozlowski T; Division of Transplantation, Department of Surgery, The University of Oklahoma College of Medicine, Oklahoma City, Oklahoma, USA.
  • Andreoni KA; Department of Surgery, University of Florida, College of Medicine, Gainesville, Florida, USA.
  • Alejandro R; Diabetes Research Institute and Cell Transplant Center, University of Miami, Miami, Florida, USA.
  • Baidal DA; Diabetes Research Institute and Cell Transplant Center, University of Miami, Miami, Florida, USA.
  • Hardy MA; Department of Surgery, Columbia University College of Physicians and Surgeons, New York, New York, USA.
  • Wickrema A; Department of Medicine, Section of Hematology and Oncology, University of Chicago, Chicago, Illinois, USA.
  • Mirmira RG; Department of Medicine, Translational Research Center, University of Chicago, Chicago, Illinois, USA.
  • Fung J; Department of Surgery, Transplantation Institute, University of Chicago, Chicago, Illinois, USA.
  • Becker YT; Department of Surgery, Transplantation Institute, University of Chicago, Chicago, Illinois, USA.
  • Josephson MA; Department of Surgery, Transplantation Institute, University of Chicago, Chicago, Illinois, USA.
  • Bachul PJ; Department of Surgery, Transplantation Institute, University of Chicago, Chicago, Illinois, USA.
  • Pyda JS; Department of Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.
  • Charlton M; Department of Surgery, Transplantation Institute, University of Chicago, Chicago, Illinois, USA.
  • Millis JM; Department of Surgery, Transplantation Institute, University of Chicago, Chicago, Illinois, USA.
  • Gaglia JL; Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts, USA.
  • Stratta RJ; Department of Surgery, Section of Transplantation, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.
  • Fridell JA; Department of Surgery, Indiana University School of Medicine, Indianapolis, Indiana, USA.
  • Niederhaus SV; Department of Surgery, University of Maryland Medical Center, Baltimore, Maryland, USA.
  • Forbes RC; Division of Kidney and Pancreas Transplantation, Department of Surgery, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
  • Jayant K; Department of Surgery, Transplantation Institute, University of Chicago, Chicago, Illinois, USA.
  • Robertson RP; Division of Endocrinology and Metabolism, Department of Internal Medicine, University of Washington, Seattle, Washington, USA.
  • Odorico JS; Division of Transplantation, Department of Surgery, University of Wisconsin, School of Medicine and Public Health, Madison, Wisconsin, USA.
  • Levy MF; Division of Transplantation, Hume-Lee Transplant Center, Virginia Commonwealth University School of Medicine, Richmond, Virginia, USA.
  • Harland RC; Department of Surgery, University of Arizona, Tucson, Arizona, USA.
  • Abrams PL; MedStar Georgetown Transplant Institute, Washington, District of Columbia, USA.
  • Olaitan OK; Department of Surgery, Rush University Medical Center, Chicago, Illinois, USA.
  • Kandaswamy R; Department of Surgery, University of Minnesota, Minneapolis, Minnesota, USA.
  • Wellen JR; Department of Surgery, Washington University, St Louis, Missouri, USA.
  • Japour AJ; Anthony Japour and Associates, Medical and Scientific Consulting Inc, Miami, FL, USA.
  • Desai CS; Department of Surgery, Section of Transplantation, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
  • Naziruddin B; Transplantation Institute, Baylor University Medical Center, Dallas, Texas, USA.
  • Balamurugan AN; Division of Pediatric General and Thoracic Surgery, Department of Surgery, Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, Ohio, USA.
  • Barth RN; Department of Surgery, Transplantation Institute, University of Chicago, Chicago, Illinois, USA.
  • Ricordi C; Diabetes Research Institute and Cell Transplant Center, University of Miami, Miami, Florida, USA.
Am J Transplant ; 21(4): 1365-1375, 2021 04.
Article en En | MEDLINE | ID: mdl-33251712
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). In contrast, across the world, human islets are appropriately defined as "minimally manipulated tissue" and not regulated as a drug, which has led to islet allotransplantation (allo-ITx) becoming a standard-of-care procedure for selected patients with type 1 diabetes mellitus. This regulatory distinction impedes patient access to islets for transplantation in the US. As a result only 11 patients underwent allo-ITx in the US between 2016 and 2019, and all as investigational procedures in the settings of a clinical trials. 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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Productos Biológicos / Trasplante de Islotes Pancreáticos / Diabetes Mellitus Tipo 1 Tipo de estudio: Health_economic_evaluation Aspecto: Ethics Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: Am J Transplant Asunto de la revista: TRANSPLANTE Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Productos Biológicos / Trasplante de Islotes Pancreáticos / Diabetes Mellitus Tipo 1 Tipo de estudio: Health_economic_evaluation Aspecto: Ethics Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: Am J Transplant Asunto de la revista: TRANSPLANTE Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos