US Food and Drug Administration (FDA) Panel Endorses Islet Cell Treatment for Type 1 Diabetes: A Pyrrhic victory?

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

doi:10.1111/tri.13930

US Food and Drug Administration (FDA) Panel Endorses Islet Cell Treatment for Type 1 Diabetes: A Pyrrhic victory?

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

Research output: Contribution to journal › Article › peer-review

Abstract / Description of output

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.

Original language	English
Journal	Transplant international
Early online date	28 May 2021
DOIs	https://doi.org/10.1111/tri.13930
Publication status	E-pub ahead of print - 28 May 2021

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FDA Panel Endorses Islet Cell Treatment for Type 1 Diabetes version 1.7Accepted author manuscript, 48.3 KB

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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. (2021). US Food and Drug Administration (FDA) Panel Endorses Islet Cell Treatment for Type 1 Diabetes: A Pyrrhic victory? Transplant international. Advance online publication. https://doi.org/10.1111/tri.13930

@article{8eee03f084ee4ce8b6add67a7e93b195,

title = "US Food and Drug Administration (FDA) Panel Endorses Islet Cell Treatment for Type 1 Diabetes: A Pyrrhic victory?",

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 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.",

author = "Lorenzo Piemonti and Axel Andres and John Casey and {de Koning}, Eelco and Marten Engelse and Robert Hilbrands and Paul Johnson and Bart Keymeulen and Julie Kerr-Conte and Olle Korsgren and Roger Lehmann and Torbj{\"o}rn Lundgren and Paola Maffi and Francois Pattou and Frantisek Saudek and James Shaw and Hanne Scholz and Steve White and Thierry Berney",

year = "2021",

month = may,

day = "28",

doi = "10.1111/tri.13930",

language = "English",

journal = "Transplant international",

issn = "0934-0874",

publisher = "Wiley-Blackwell",

}

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 2021, 'US Food and Drug Administration (FDA) Panel Endorses Islet Cell Treatment for Type 1 Diabetes: A Pyrrhic victory?', Transplant international. https://doi.org/10.1111/tri.13930

TY - JOUR

T1 - US Food and Drug Administration (FDA) Panel Endorses Islet Cell Treatment for Type 1 Diabetes

T2 - A Pyrrhic victory?

AU - Piemonti, Lorenzo

AU - Andres, Axel

AU - Casey, John

AU - de Koning, Eelco

AU - Engelse, Marten

AU - Hilbrands, Robert

AU - Johnson, Paul

AU - Keymeulen, Bart

AU - Kerr-Conte, Julie

AU - Korsgren, Olle

AU - Lehmann, Roger

AU - Lundgren, Torbjörn

AU - Maffi, Paola

AU - Pattou, Francois

AU - Saudek, Frantisek

AU - Shaw, James

AU - Scholz, Hanne

AU - White, Steve

AU - Berney, Thierry

PY - 2021/5/28

Y1 - 2021/5/28

N2 - 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.

AB - 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.

U2 - 10.1111/tri.13930

DO - 10.1111/tri.13930

M3 - Article

C2 - 34048106

SN - 0934-0874

JO - Transplant international

JF - Transplant international

ER -

US Food and Drug Administration (FDA) Panel Endorses Islet Cell Treatment for Type 1 Diabetes: A Pyrrhic victory?

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