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US food and drug administration (FDA) panel endorses islet cell treatment for type 1 diabetes : A pyrrhic victory?
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- Piemonti, Lorenzo (author)
- Osped San Raffaele, IRCCS, Diabet Res Inst, Milan, Italy.
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- Andres, Axel (author)
- Geneva Univ Hosp, Dept Surg, Geneva, Switzerland.
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- Casey, John (author)
- Royal Infirm Edinburgh NHS Trust, Edinburgh Transplant Ctr, Edinburgh, Midlothian, Scotland.
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- de Koning, Eelco (author)
- Leiden Univ, Med Ctr, Dept Internal Med, Leiden, Netherlands.;Leiden Univ, Med Ctr, Transplantat Ctr, Leiden, Netherlands.
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- Engelse, Marten (author)
- Leiden Univ, Med Ctr, Dept Internal Med, Leiden, Netherlands.;Leiden Univ, Med Ctr, Transplantat Ctr, Leiden, Netherlands.
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- Hilbrands, Robert (author)
- Vrije Univ Brussel VUB, Diabet Res Ctr DRC, Brussels, Belgium.
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- Johnson, Paul (author)
- Univ Oxford, Nuffield Dept Surg Sci, Oxford, England.;Univ Oxford, Oxford Ctr Diabet Endocrinol & Metab OCDEM, Oxford Biomed Res Ctr OxBRC, Oxford, England.
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- Keymeulen, Bart (author)
- Vrije Univ Brussel VUB, Diabet Res Ctr DRC, Brussels, Belgium.
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- Kerr-Conte, Julie (author)
- Univ Lille, European Genom Inst Diabet, INSERM,U1190, Translat Res Diabet,CHU Lille,Lille Pasteur Inst, Lille, France.
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- Korsgren, Olle (author)
- Uppsala universitet,Klinisk immunologi
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- Lehmann, Roger (author)
- Univ Hosp Zurich, Dept Endocrinol Diabet & Clin Nutr, Zurich, Switzerland.
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- Lundgren, Torbjorn (author)
- Karolinska Univ Hosp, Karolinska Inst, CLINTEC, Div Transplantat Surg, Stockholm, Sweden.
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- Maffi, Paola (author)
- Osped San Raffaele, IRCCS, Diabet Res Inst, Milan, Italy.
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- Pattou, Francois (author)
- Univ Lille, European Genom Inst Diabet, INSERM,U1190, Translat Res Diabet,CHU Lille,Lille Pasteur Inst, Lille, France.
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- Saudek, Frantisek (author)
- Inst Clin & Expt Med, Diabet Ctr, Prague, Czech Republic.
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- Shaw, James (author)
- Newcastle Univ, Translat & Clin Res Inst, Newcastle Upon Tyne, Tyne & Wear, England.
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- Scholz, Hanne (author)
- Oslo Univ Hosp, Dept Transplantat Med, Oslo, Norway.;Freeman Rd Hosp, Dept HPB & Transplant Surg, Newcastle Upon Tyne, Tyne & Wear, England.
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White, Steve (author)
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- Berney, Thierry (author)
- Geneva Univ Hosp, Dept Surg, Geneva, Switzerland.
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Osped San Raffaele, IRCCS, Diabet Res Inst, Milan, Italy Geneva Univ Hosp, Dept Surg, Geneva, Switzerland. (creator_code:org_t)
- 2021-06-11
- 2021
- English.
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In: Transplant International. - : John Wiley & Sons. - 0934-0874 .- 1432-2277. ; 34:7, s. 1182-1186
- Related links:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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http://kipublication...
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Abstract
Subject headings
Close
- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Endokrinologi och diabetes (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Endocrinology and Diabetes (hsv//eng)
Keyword
- European medicines agency
- food and drug administration
- pancreatic islet transplantation
- regulatory authorities
Publication and Content Type
- vet (subject category)
- art (subject category)
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- By the author/editor
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Piemonti, Lorenz ...
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Andres, Axel
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Casey, John
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de Koning, Eelco
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Engelse, Marten
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Hilbrands, Rober ...
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show more...
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Johnson, Paul
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Keymeulen, Bart
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Kerr-Conte, Juli ...
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Korsgren, Olle
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Lehmann, Roger
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Lundgren, Torbjo ...
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Maffi, Paola
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Pattou, Francois
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Saudek, Frantise ...
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Shaw, James
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Scholz, Hanne
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White, Steve
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Berney, Thierry
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Endocrinology an ...
- Articles in the publication
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Transplant Inter ...
- By the university
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Uppsala University
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Karolinska Institutet