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Regulation of stem cell therapies under attack in Europe: for whom the bell tolls

Bianco, Paolo ; Barker, Roger ; Bruestle, Oliver ; Cattaneo, Elena ; Clevers, Hans ; Daley, George Q. ; De Luca, Michele ; Goldstein, Lawrence ; Lindvall, Olle LU and Mummery, Christine , et al. (2013) In EMBO Journal 32(11). p.1489-1495
Abstract
At the time of writing, the Italian Parliament is debating a new law that would make it legal to practice an unproven stem cell treatment in public hospitals. The treatment, offered by a private non-medical organization, may not be safe, lacks a rationale, and violates current national laws and European regulations. This case raises multiple concerns, most prominently the urgent need to protect patients who are severely ill, exposed to significant risks, and vulnerable to exploitation. The scientific community must consider the context-social, financial, medical, legal-in which stem cell science is currently situated and the need for stringent regulation. Additional concerns are emerging. These emanate from the novel climate, created... (More)
At the time of writing, the Italian Parliament is debating a new law that would make it legal to practice an unproven stem cell treatment in public hospitals. The treatment, offered by a private non-medical organization, may not be safe, lacks a rationale, and violates current national laws and European regulations. This case raises multiple concerns, most prominently the urgent need to protect patients who are severely ill, exposed to significant risks, and vulnerable to exploitation. The scientific community must consider the context-social, financial, medical, legal-in which stem cell science is currently situated and the need for stringent regulation. Additional concerns are emerging. These emanate from the novel climate, created within science itself, and stem cell science in particular, by the currently prevailing model of 'translational medicine'. Only rigorous science and rigorous regulation can ensure translation of science into effective therapies rather than into ineffective market products, and mark, at the same time, the sharp distinction between the striving for new therapies and the deceit of patients. (Less)
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organization
publishing date
type
Contribution to journal
publication status
published
subject
in
EMBO Journal
volume
32
issue
11
pages
1489 - 1495
publisher
Oxford University Press
external identifiers
  • wos:000319562800001
  • scopus:84878577939
  • pmid:23644381
ISSN
1460-2075
DOI
10.1038/emboj.2013.114
language
English
LU publication?
yes
additional info
The information about affiliations in this record was updated in December 2015. The record was previously connected to the following departments: Restorative Neurology (0131000160)
id
be2a1210-212f-447b-8506-c15bc6f9dded (old id 3931092)
date added to LUP
2016-04-01 12:59:47
date last changed
2022-01-27 08:40:35
@misc{be2a1210-212f-447b-8506-c15bc6f9dded,
  abstract     = {{At the time of writing, the Italian Parliament is debating a new law that would make it legal to practice an unproven stem cell treatment in public hospitals. The treatment, offered by a private non-medical organization, may not be safe, lacks a rationale, and violates current national laws and European regulations. This case raises multiple concerns, most prominently the urgent need to protect patients who are severely ill, exposed to significant risks, and vulnerable to exploitation. The scientific community must consider the context-social, financial, medical, legal-in which stem cell science is currently situated and the need for stringent regulation. Additional concerns are emerging. These emanate from the novel climate, created within science itself, and stem cell science in particular, by the currently prevailing model of 'translational medicine'. Only rigorous science and rigorous regulation can ensure translation of science into effective therapies rather than into ineffective market products, and mark, at the same time, the sharp distinction between the striving for new therapies and the deceit of patients.}},
  author       = {{Bianco, Paolo and Barker, Roger and Bruestle, Oliver and Cattaneo, Elena and Clevers, Hans and Daley, George Q. and De Luca, Michele and Goldstein, Lawrence and Lindvall, Olle and Mummery, Christine and Robey, Pamela G. and de Sousa e Brito, Clara Sattler and Smith, Austin}},
  issn         = {{1460-2075}},
  language     = {{eng}},
  number       = {{11}},
  pages        = {{1489--1495}},
  publisher    = {{Oxford University Press}},
  series       = {{EMBO Journal}},
  title        = {{Regulation of stem cell therapies under attack in Europe: for whom the bell tolls}},
  url          = {{http://dx.doi.org/10.1038/emboj.2013.114}},
  doi          = {{10.1038/emboj.2013.114}},
  volume       = {{32}},
  year         = {{2013}},
}