US Food and Drug Administration (FDA) Panel ...
Document type :
Article dans une revue scientifique: Article original
DOI :
PMID :
Permalink :
Title :
US Food and Drug Administration (FDA) Panel Endorses Islet Cell Treatment for Type 1 Diabetes: A Pyrrhic victory?
Author(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]
Journal title :
Transplant International
Abbreviated title :
Transpl Int
Volume number :
34
Pages :
1182-1186
Publisher :
Frontiers Media
Publication date :
2021-05-28
ISSN :
1432-2277
English keyword(s) :
European medicines agency
food and drug administration
pancreatic islet transplantation
regulatory authorities
food and drug administration
pancreatic islet transplantation
regulatory authorities
HAL domain(s) :
Sciences du Vivant [q-bio]
English abstract : [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 ...
Show more >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.Show less >
Show more >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.Show less >
Language :
Anglais
Peer reviewed article :
Oui
Audience :
Internationale
Popular science :
Non
Administrative institution(s) :
Université de Lille
Inserm
CHU Lille
Inserm
CHU Lille
Collections :
Submission date :
2024-01-19T22:58:15Z
2024-10-29T15:09:23Z
2024-10-29T15:09:23Z