US Food and Drug Administration (FDA) Panel ...
Type de document :
Article dans une revue scientifique: Article original
DOI :
PMID :
URL permanente :
Titre :
US Food and Drug Administration (FDA) Panel Endorses Islet Cell Treatment for Type 1 Diabetes: A Pyrrhic victory?
Auteur(s) :
Piemonti, Lorenzo [Auteur]
IRCCS Ospedale San Raffaele [Milan, Italy]
Andres, Axel [Auteur]
Hôpitaux universitaires de Genève = University Hospitals of Geneva [HUG]
Casey, John [Auteur]
Royal Infirmary of Edinburgh
De Koning, Eelco [Auteur]
Leiden University Medical Center [LUMC]
Engelse, Marten [Auteur]
Leiden University Medical Center [LUMC]
Hilbrands, Robert [Auteur]
Vrije Universiteit Brussel [Bruxelles] [VUB]
Johnson, Paul [Auteur]
University of Oxford
Keymeulen, Bart [Auteur]
Vrije Universiteit Brussel [Bruxelles] [VUB]
Pattou Kerr-Conte, Julie [Auteur]
Recherche translationnelle sur le diabète (RTD) - U1190
Korsgren, Olle [Auteur]
Uppsala University Hospital
Lehmann, Roger [Auteur]
University hospital of Zurich [Zurich]
Lundgren, Torbjörn [Auteur]
Karolinska University Hospital [Stockholm]
Maffi, Paola [Auteur]
IRCCS Ospedale San Raffaele [Milan, Italy]
Pattou, Francois [Auteur]
Recherche translationnelle sur le diabète (RTD) - U1190
Saudek, Frantisek [Auteur]
Institute for Clinical and Experimental Medicine [IKEM]
Shaw, James [Auteur]
Newcastle University [Newcastle]
Scholz, Hanne [Auteur]
Oslo University Hospital [Oslo]
White, Steve [Auteur]
Freeman Hospital
Berney, Thierry [Auteur]
Hôpitaux universitaires de Genève = University Hospitals of Geneva [HUG]
IRCCS Ospedale San Raffaele [Milan, Italy]
Andres, Axel [Auteur]
Hôpitaux universitaires de Genève = University Hospitals of Geneva [HUG]
Casey, John [Auteur]
Royal Infirmary of Edinburgh
De Koning, Eelco [Auteur]
Leiden University Medical Center [LUMC]
Engelse, Marten [Auteur]
Leiden University Medical Center [LUMC]
Hilbrands, Robert [Auteur]
Vrije Universiteit Brussel [Bruxelles] [VUB]
Johnson, Paul [Auteur]
University of Oxford
Keymeulen, Bart [Auteur]
Vrije Universiteit Brussel [Bruxelles] [VUB]
Pattou Kerr-Conte, Julie [Auteur]
Recherche translationnelle sur le diabète (RTD) - U1190
Korsgren, Olle [Auteur]
Uppsala University Hospital
Lehmann, Roger [Auteur]
University hospital of Zurich [Zurich]
Lundgren, Torbjörn [Auteur]
Karolinska University Hospital [Stockholm]
Maffi, Paola [Auteur]
IRCCS Ospedale San Raffaele [Milan, Italy]
Pattou, Francois [Auteur]
Recherche translationnelle sur le diabète (RTD) - U1190
Saudek, Frantisek [Auteur]
Institute for Clinical and Experimental Medicine [IKEM]
Shaw, James [Auteur]
Newcastle University [Newcastle]
Scholz, Hanne [Auteur]
Oslo University Hospital [Oslo]
White, Steve [Auteur]
Freeman Hospital
Berney, Thierry [Auteur]
Hôpitaux universitaires de Genève = University Hospitals of Geneva [HUG]
Titre de la revue :
Transplant International
Nom court de la revue :
Transpl Int
Numéro :
34
Pagination :
1182-1186
Éditeur :
Frontiers Media
Date de publication :
2021-05-28
ISSN :
1432-2277
Mot(s)-clé(s) en anglais :
European medicines agency
food and drug administration
pancreatic islet transplantation
regulatory authorities
food and drug administration
pancreatic islet transplantation
regulatory authorities
Discipline(s) HAL :
Sciences du Vivant [q-bio]
Résumé en anglais : [en]
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 ...
Lire la suite >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 US 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.Lire moins >
Lire la suite >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 US 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.Lire moins >
Langue :
Anglais
Comité de lecture :
Oui
Audience :
Internationale
Vulgarisation :
Non
Établissement(s) :
Université de Lille
Inserm
CHU Lille
Inserm
CHU Lille
Collections :
Date de dépôt :
2024-01-19T22:58:15Z
2024-10-29T15:09:23Z
2024-10-29T15:09:23Z