如何规范干细胞治疗（意大利）在欧洲引起争论，Nature（EMBO）发表文章

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COMMENTARY! K9 q  K, r8 i7 z# q) Z4 A

. u  \$ r9 d, S2 t; J, CThe EMBO Journal advance online publication 3 May 2013; doi:10.1038/emboj.2013.114
0 I4 @' T" m, R7 TPublished online: 3 May 2013
8 ?, P/ h# |* {$ t5 HRegulation of stem cell therapies under attack in Europe: for whom the bell tolls4 T; v) s2 m) c/ ]' q

! K0 @5 Z$ o% R( z4 E# Q0 `Paolo Bianco1, Roger Barker2, Oliver Brüstle3, Elena Cattaneo4, Hans Clevers5, George Q Daley6, Michele De Luca7, Lawrence Goldstein8, Olle Lindvall9, Christine Mummery10, Pamela G Robey11,14, Clara Sattler de Sousa e Brito12 and Austin Smith13
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Department of Molecular Medicine, University of Rome ‘La Sapienza’, Rome, Italy
+ H; y1 s9 ^$ ~John van Geest Centre for Brain Repair, School of Clinical Medicine, University of Cambridge, Cambridge, UK, N; [$ M4 `9 I1 K1 |% R* g$ C
Institute of Reconstructive Neurobiology, LIFE & BRAIN Centre, University of Bonn, Bonn, Germany
, H% T  @" g2 [# NDepartment of Biosciences and Centre of Stem Cell Research (UniStem), University of Milan, Milan, Italy5 q! U6 m2 ?* j
Hubrecht Institute, Utrecht, The Netherlands
* d* k5 z" j* A& E% a# E, AHarvard Stem Cell Institute, Cambridge, MA, USA
# j! ~1 b, R5 s5 aCenter for Regenerative Medicine ‘Stefano Ferrari’, University of Modena and Reggio Emilia, Modena, Italy5 ?! B# V5 a+ X0 ]8 y" r
Department of Cellular and Molecular Medicine and Department of Neurosciences University of California at San Diego School of Medicine, San Diego, CA, USA
4 b% c7 ~1 w7 D7 X) V7 T0 fLund Stem Cell Center, University Hospital, Lund, Sweden
; J) \) o4 ], E1 z, ]Department of Anatomy and Embryology, Leiden University Medical Center, Leiden, The Netherlands6 k( x: s( B2 K4 c6 o
National Institute of Dental and Craniofacial Research, National Institutes of Health, Bethesda, MD, USA
1 T! f6 u1 S% D( O# e* zFaculty of Law, Universidade Católica, Lisbon, Portugal
# ]. ~# a8 {' P& AWellcome Trust-Medical Research Council Stem Cell Institute, University of Cambridge, Cambridge, UK
- {# Y/ J- A% _7 A9 pCorrespondence to:: s3 T9 h7 D* @. |! J: [5 ^' l
Paolo Bianco, Departmento di Medicina Sperimentale, University of Rome ‘La Sapienza’, Rome, Italy. E-mail: paolo.bianco@uniroma1.it9 j6 z# f  F2 O. y- [5 U
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14This manuscript reflects the opinons of this author and not those of the National Institutes of Health or the U.S. Federal Government.
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Received 29 April 2013; Accepted 29 April 2013: Y( J# i5 g! q, B

+ k3 d' |! \7 P8 T" X1 KAt 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.