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

Lookup NU author(s): Professor James Shaw, Steven White


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© 2021 Steunstichting ESOT. Published by John Wiley & Sons LtdAllogeneic 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.

Publication metadata

Author(s): Piemonti L, Andres A, Casey J, de Koning E, Engelse M, Hilbrands R, Johnson P, Keymeulen B, Kerr-Conte J, Korsgren O, Lehmann R, Lundgren T, Maffi P, Pattou F, Saudek F, Shaw J, Scholz H, White S, Berney T

Publication type: Article

Publication status: Published

Journal: Transplant International

Year: 2021

Volume: 34

Issue: 7

Pages: 1182-1186

Online publication date: 28/05/2021

Acceptance date: 24/05/2021

ISSN (print): 0934-0874

ISSN (electronic): 1432-2277

Publisher: Blackwell Publishing Ltd


DOI: 10.1111/tri.13930

PubMed id: 34048106


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