US food and drug administration (FDA) panel endorses islet cell treatment for type 1 diabetes: A pyrrhic victory?
Summary 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 treatme...
Gespeichert in:
| Veröffentlicht in: | Transplant international 2021-07, Vol.34 (7), p.1182-1186 |
|---|---|
| Hauptverfasser: | , , , , , , , , , , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 1186 |
|---|---|
| container_issue | 7 |
| container_start_page | 1182 |
| container_title | Transplant international |
| container_volume | 34 |
| creator | Piemonti, Lorenzo Andres, Axel Casey, John Koning, Eelco Engelse, Marten Hilbrands, Robert Johnson, Paul Keymeulen, Bart Kerr‐Conte, Julie Korsgren, Olle Lehmann, Roger Lundgren, Torbjörn Maffi, Paola Pattou, Francois Saudek, Frantisek Shaw, James Scholz, Hanne White, Steve Berney, Thierry |
| description | Summary
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. |
| doi_str_mv | 10.1111/tri.13930 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_swepu</sourceid><recordid>TN_cdi_swepub_primary_oai_swepub_ki_se_640429</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2553640956</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4740-1fab42abe878c5afc3a3baaa7a0ae5d9da32e3023df0fa432e19b0bd9fed6cf23</originalsourceid><addsrcrecordid>eNp10lFr1TAUAOAgirtOH_wHAV82sFvSpE3ryyibc4MLgm6-htPmdMvsbbok3ei_N9c7FIXlJeHw5eTkcAh5z9kRT-s4envERS3YC7LiUuRZniv1kqxYLWTGKiX3yJsQ7hhjeVWw12RPSCYrzsoVub_-TnvnDIXRUOPnGwpmY0cboodo3UgPzs-aQzrBiAPF0TgfMFAbBoy0w2Gg0SPEDY4xpfE0LhNSTo2FFiOGT7Sh0-L9re3og-2i88vJW_KqhyHgu6d9n1yff746vcjWX79cnjbrrJNKsoz30Mo8palU1RXQdwJECwAKGGBhagMiR8FyYXrWQ_o08rplral7NGXX52KfZLu84RGnudWTtxvwi3Zg9VPoZzqhLlMz8jr5j8_6M_uj0c7f6HnWUjFVqcQPd_wWhn_sRbPW2xiTqqhqwR94sgc7O3l3P2OIemPDtnupq24OOi-ELHnB6jLRD__ROzf7MTUqqUKkWuui_Pt4510IHvs_FXCmtyOh00jo3yOR7PHOPtoBl-ehvvp2ubvxCz0Rtok</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2553640956</pqid></control><display><type>article</type><title>US food and drug administration (FDA) panel endorses islet cell treatment for type 1 diabetes: A pyrrhic victory?</title><source>Wiley Online Library - AutoHoldings Journals</source><source>EZB-FREE-00999 freely available EZB journals</source><creator>Piemonti, Lorenzo ; Andres, Axel ; Casey, John ; Koning, Eelco ; Engelse, Marten ; Hilbrands, Robert ; Johnson, Paul ; Keymeulen, Bart ; Kerr‐Conte, Julie ; Korsgren, Olle ; Lehmann, Roger ; Lundgren, Torbjörn ; Maffi, Paola ; Pattou, Francois ; Saudek, Frantisek ; Shaw, James ; Scholz, Hanne ; White, Steve ; Berney, Thierry</creator><creatorcontrib>Piemonti, Lorenzo ; Andres, Axel ; Casey, John ; Koning, Eelco ; Engelse, Marten ; Hilbrands, Robert ; Johnson, Paul ; Keymeulen, Bart ; Kerr‐Conte, Julie ; Korsgren, Olle ; Lehmann, Roger ; Lundgren, Torbjörn ; Maffi, Paola ; Pattou, Francois ; Saudek, Frantisek ; Shaw, James ; Scholz, Hanne ; White, Steve ; Berney, Thierry</creatorcontrib><description>Summary
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.</description><identifier>ISSN: 0934-0874</identifier><identifier>ISSN: 1432-2277</identifier><identifier>EISSN: 1432-2277</identifier><identifier>DOI: 10.1111/tri.13930</identifier><identifier>PMID: 34048106</identifier><language>eng</language><publisher>Groningen: Blackwell Publishing Ltd</publisher><subject>Commercialization ; Diabetes ; Diabetes mellitus ; Diabetes mellitus (insulin dependent) ; European medicines agency ; food and drug administration ; Human tissues ; Islet cells ; Life Sciences ; Pancreatic islet transplantation ; regulatory authorities ; Transplantation</subject><ispartof>Transplant international, 2021-07, Vol.34 (7), p.1182-1186</ispartof><rights>2021 Steunstichting ESOT. Published by John Wiley & Sons Ltd</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4740-1fab42abe878c5afc3a3baaa7a0ae5d9da32e3023df0fa432e19b0bd9fed6cf23</citedby><cites>FETCH-LOGICAL-c4740-1fab42abe878c5afc3a3baaa7a0ae5d9da32e3023df0fa432e19b0bd9fed6cf23</cites><orcidid>0000-0002-4230-9378 ; 0000-0002-7590-1896 ; 0000-0002-2172-2198</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Ftri.13930$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Ftri.13930$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>230,314,780,784,885,1416,27922,27923,45572,45573</link.rule.ids><backlink>$$Uhttps://hal.univ-lille.fr/hal-04758931$$DView record in HAL$$Hfree_for_read</backlink><backlink>$$Uhttps://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-470787$$DView record from Swedish Publication Index$$Hfree_for_read</backlink><backlink>$$Uhttp://kipublications.ki.se/Default.aspx?queryparsed=id:146835208$$DView record from Swedish Publication Index$$Hfree_for_read</backlink></links><search><creatorcontrib>Piemonti, Lorenzo</creatorcontrib><creatorcontrib>Andres, Axel</creatorcontrib><creatorcontrib>Casey, John</creatorcontrib><creatorcontrib>Koning, Eelco</creatorcontrib><creatorcontrib>Engelse, Marten</creatorcontrib><creatorcontrib>Hilbrands, Robert</creatorcontrib><creatorcontrib>Johnson, Paul</creatorcontrib><creatorcontrib>Keymeulen, Bart</creatorcontrib><creatorcontrib>Kerr‐Conte, Julie</creatorcontrib><creatorcontrib>Korsgren, Olle</creatorcontrib><creatorcontrib>Lehmann, Roger</creatorcontrib><creatorcontrib>Lundgren, Torbjörn</creatorcontrib><creatorcontrib>Maffi, Paola</creatorcontrib><creatorcontrib>Pattou, Francois</creatorcontrib><creatorcontrib>Saudek, Frantisek</creatorcontrib><creatorcontrib>Shaw, James</creatorcontrib><creatorcontrib>Scholz, Hanne</creatorcontrib><creatorcontrib>White, Steve</creatorcontrib><creatorcontrib>Berney, Thierry</creatorcontrib><title>US food and drug administration (FDA) panel endorses islet cell treatment for type 1 diabetes: A pyrrhic victory?</title><title>Transplant international</title><description>Summary
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.</description><subject>Commercialization</subject><subject>Diabetes</subject><subject>Diabetes mellitus</subject><subject>Diabetes mellitus (insulin dependent)</subject><subject>European medicines agency</subject><subject>food and drug administration</subject><subject>Human tissues</subject><subject>Islet cells</subject><subject>Life Sciences</subject><subject>Pancreatic islet transplantation</subject><subject>regulatory authorities</subject><subject>Transplantation</subject><issn>0934-0874</issn><issn>1432-2277</issn><issn>1432-2277</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><recordid>eNp10lFr1TAUAOAgirtOH_wHAV82sFvSpE3ryyibc4MLgm6-htPmdMvsbbok3ei_N9c7FIXlJeHw5eTkcAh5z9kRT-s4envERS3YC7LiUuRZniv1kqxYLWTGKiX3yJsQ7hhjeVWw12RPSCYrzsoVub_-TnvnDIXRUOPnGwpmY0cboodo3UgPzs-aQzrBiAPF0TgfMFAbBoy0w2Gg0SPEDY4xpfE0LhNSTo2FFiOGT7Sh0-L9re3og-2i88vJW_KqhyHgu6d9n1yff746vcjWX79cnjbrrJNKsoz30Mo8palU1RXQdwJECwAKGGBhagMiR8FyYXrWQ_o08rplral7NGXX52KfZLu84RGnudWTtxvwi3Zg9VPoZzqhLlMz8jr5j8_6M_uj0c7f6HnWUjFVqcQPd_wWhn_sRbPW2xiTqqhqwR94sgc7O3l3P2OIemPDtnupq24OOi-ELHnB6jLRD__ROzf7MTUqqUKkWuui_Pt4510IHvs_FXCmtyOh00jo3yOR7PHOPtoBl-ehvvp2ubvxCz0Rtok</recordid><startdate>202107</startdate><enddate>202107</enddate><creator>Piemonti, Lorenzo</creator><creator>Andres, Axel</creator><creator>Casey, John</creator><creator>Koning, Eelco</creator><creator>Engelse, Marten</creator><creator>Hilbrands, Robert</creator><creator>Johnson, Paul</creator><creator>Keymeulen, Bart</creator><creator>Kerr‐Conte, Julie</creator><creator>Korsgren, Olle</creator><creator>Lehmann, Roger</creator><creator>Lundgren, Torbjörn</creator><creator>Maffi, Paola</creator><creator>Pattou, Francois</creator><creator>Saudek, Frantisek</creator><creator>Shaw, James</creator><creator>Scholz, Hanne</creator><creator>White, Steve</creator><creator>Berney, Thierry</creator><general>Blackwell Publishing Ltd</general><general>Frontiers Media</general><scope>AAYXX</scope><scope>CITATION</scope><scope>7QO</scope><scope>7T5</scope><scope>8FD</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>P64</scope><scope>7X8</scope><scope>1XC</scope><scope>ADTPV</scope><scope>AOWAS</scope><scope>BTSUP</scope><scope>DF2</scope><orcidid>https://orcid.org/0000-0002-4230-9378</orcidid><orcidid>https://orcid.org/0000-0002-7590-1896</orcidid><orcidid>https://orcid.org/0000-0002-2172-2198</orcidid></search><sort><creationdate>202107</creationdate><title>US food and drug administration (FDA) panel endorses islet cell treatment for type 1 diabetes: A pyrrhic victory?</title><author>Piemonti, Lorenzo ; Andres, Axel ; Casey, John ; Koning, Eelco ; Engelse, Marten ; Hilbrands, Robert ; Johnson, Paul ; Keymeulen, Bart ; Kerr‐Conte, Julie ; Korsgren, Olle ; Lehmann, Roger ; Lundgren, Torbjörn ; Maffi, Paola ; Pattou, Francois ; Saudek, Frantisek ; Shaw, James ; Scholz, Hanne ; White, Steve ; Berney, Thierry</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4740-1fab42abe878c5afc3a3baaa7a0ae5d9da32e3023df0fa432e19b0bd9fed6cf23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Commercialization</topic><topic>Diabetes</topic><topic>Diabetes mellitus</topic><topic>Diabetes mellitus (insulin dependent)</topic><topic>European medicines agency</topic><topic>food and drug administration</topic><topic>Human tissues</topic><topic>Islet cells</topic><topic>Life Sciences</topic><topic>Pancreatic islet transplantation</topic><topic>regulatory authorities</topic><topic>Transplantation</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Piemonti, Lorenzo</creatorcontrib><creatorcontrib>Andres, Axel</creatorcontrib><creatorcontrib>Casey, John</creatorcontrib><creatorcontrib>Koning, Eelco</creatorcontrib><creatorcontrib>Engelse, Marten</creatorcontrib><creatorcontrib>Hilbrands, Robert</creatorcontrib><creatorcontrib>Johnson, Paul</creatorcontrib><creatorcontrib>Keymeulen, Bart</creatorcontrib><creatorcontrib>Kerr‐Conte, Julie</creatorcontrib><creatorcontrib>Korsgren, Olle</creatorcontrib><creatorcontrib>Lehmann, Roger</creatorcontrib><creatorcontrib>Lundgren, Torbjörn</creatorcontrib><creatorcontrib>Maffi, Paola</creatorcontrib><creatorcontrib>Pattou, Francois</creatorcontrib><creatorcontrib>Saudek, Frantisek</creatorcontrib><creatorcontrib>Shaw, James</creatorcontrib><creatorcontrib>Scholz, Hanne</creatorcontrib><creatorcontrib>White, Steve</creatorcontrib><creatorcontrib>Berney, Thierry</creatorcontrib><collection>CrossRef</collection><collection>Biotechnology Research Abstracts</collection><collection>Immunology Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><collection>SwePub</collection><collection>SwePub Articles</collection><collection>SwePub Editorial</collection><collection>SWEPUB Uppsala universitet</collection><jtitle>Transplant international</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Piemonti, Lorenzo</au><au>Andres, Axel</au><au>Casey, John</au><au>Koning, Eelco</au><au>Engelse, Marten</au><au>Hilbrands, Robert</au><au>Johnson, Paul</au><au>Keymeulen, Bart</au><au>Kerr‐Conte, Julie</au><au>Korsgren, Olle</au><au>Lehmann, Roger</au><au>Lundgren, Torbjörn</au><au>Maffi, Paola</au><au>Pattou, Francois</au><au>Saudek, Frantisek</au><au>Shaw, James</au><au>Scholz, Hanne</au><au>White, Steve</au><au>Berney, Thierry</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>US food and drug administration (FDA) panel endorses islet cell treatment for type 1 diabetes: A pyrrhic victory?</atitle><jtitle>Transplant international</jtitle><date>2021-07</date><risdate>2021</risdate><volume>34</volume><issue>7</issue><spage>1182</spage><epage>1186</epage><pages>1182-1186</pages><issn>0934-0874</issn><issn>1432-2277</issn><eissn>1432-2277</eissn><abstract>Summary
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.</abstract><cop>Groningen</cop><pub>Blackwell Publishing Ltd</pub><pmid>34048106</pmid><doi>10.1111/tri.13930</doi><tpages>5</tpages><orcidid>https://orcid.org/0000-0002-4230-9378</orcidid><orcidid>https://orcid.org/0000-0002-7590-1896</orcidid><orcidid>https://orcid.org/0000-0002-2172-2198</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0934-0874 |
| ispartof | Transplant international, 2021-07, Vol.34 (7), p.1182-1186 |
| issn | 0934-0874 1432-2277 1432-2277 |
| language | eng |
| recordid | cdi_swepub_primary_oai_swepub_ki_se_640429 |
| source | Wiley Online Library - AutoHoldings Journals; EZB-FREE-00999 freely available EZB journals |
| subjects | Commercialization Diabetes Diabetes mellitus Diabetes mellitus (insulin dependent) European medicines agency food and drug administration Human tissues Islet cells Life Sciences Pancreatic islet transplantation regulatory authorities Transplantation |
| title | US food and drug administration (FDA) panel endorses islet cell treatment for type 1 diabetes: A pyrrhic victory? |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-14T13%3A28%3A05IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_swepu&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=US%20food%20and%20drug%20administration%20(FDA)%20panel%20endorses%20islet%20cell%20treatment%20for%20type%201%20diabetes:%20A%20pyrrhic%20victory?&rft.jtitle=Transplant%20international&rft.au=Piemonti,%20Lorenzo&rft.date=2021-07&rft.volume=34&rft.issue=7&rft.spage=1182&rft.epage=1186&rft.pages=1182-1186&rft.issn=0934-0874&rft.eissn=1432-2277&rft_id=info:doi/10.1111/tri.13930&rft_dat=%3Cproquest_swepu%3E2553640956%3C/proquest_swepu%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2553640956&rft_id=info:pmid/34048106&rfr_iscdi=true |