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4. US food and drug administration (FDA) panel endorses islet cell treatment for type 1 diabetes: A pyrrhic victory?

Author

Piemonti, Lorenzo, primary, Andres, Axel, additional, Casey, John, additional, Koning, Eelco, additional, Engelse, Marten, additional, Hilbrands, Robert, additional, Johnson, Paul, additional, Keymeulen, Bart, additional, Kerr‐Conte, Julie, additional, Korsgren, Olle, additional, Lehmann, Roger, additional, Lundgren, Torbjörn, additional, Maffi, Paola, additional, Pattou, Francois, additional, Saudek, Frantisek, additional, Shaw, James, additional, Scholz, Hanne, additional, White, Steve, additional, and Berney, Thierry, additional

Published
2021
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13. US food and drug administration (FDA) panel endorses islet cell treatment for type 1 diabetes: A pyrrhic victory?

Author

Paola Maffi, Marten A. Engelse, Steve White, Robert Hilbrands, Frantisek Saudek, Axel Andres, Torbjörn Lundgren, Paul Johnson, Roger Lehmann, Thierry Berney, Lorenzo Piemonti, John Casey, Eelco J.P. de Koning, Julie Kerr-Conte, Bart Keymeulen, François Pattou, James Shaw, Olle Korsgren, Hanne Scholz, Pathology/molecular and cellular medicine, Chemical Engineering and Industrial Chemistry, Diabetes Clinic, Diabetes Pathology & Therapy, Piemonti, Lorenzo, Andres, Axel, Casey, John, de Koning, Eelco, Engelse, Marten, Hilbrands, Robert, Johnson, Paul, Keymeulen, Bart, Kerr-Conte, Julie, Korsgren, Olle, Lehmann, Roger, Lundgren, Torbjörn, Maffi, Paola, Pattou, Francoi, Saudek, Frantisek, Shaw, Jame, Scholz, Hanne, White, Steve, and Berney, Thierry

Subjects
medicine.medical_specialty, pancreatic islet transplantation, Islets of Langerhans Transplantation, 030230 surgery, European medicines agency, Food and drug administration, Islets of Langerhans, 03 medical and health sciences, 0302 clinical medicine, Japan, Humans, Regulatory authorities, Medicine, Intensive care medicine, food and drug administration, Licensure, Transplantation, geography, Type 1 diabetes, geography.geographical_feature_category, ddc:617, Ethical issues, United States Food and Drug Administration, business.industry, Australia, Islet, medicine.disease, United Kingdom, United States, Europe, Diabetes Mellitus, Type 1, regulatory authorities, Pyrrhic victory, 030211 gastroenterology & hepatology, Pancreatic islet transplantation, business
Abstract

Allogeneic islet transplantation is a standard of care treatment for patients with labile type 1 diabetes in many countries around the world, including Japan, the United Kingdom, Australia, much of continental Europe, and parts of Canada. The United States is now endorsing islet cell treatment for type 1 diabetes, but the FDA has chosen to consider islets as a biologic that requires licensure, making the universal implementation of the procedure in the clinic very challenging and opening the manufacture of islet grafts to private companies. The commercialization of human tissues raises significant legal and ethical issues and ironically leads to a situation where treatments developed as a result of the scientific and economic efforts of academia over several decades become exploited exclusively by for-profit entities.

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