title: Regulation of stem cell therapies under attack in Europe: for whom the bell tolls.
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.
authors: Department of Molecular Medicine, University of Rome La Sapienza, Rome, Italy. paolo.bianco@uniroma1.it
authors: Paolo
authors: P
authors: Bianco
authors: Roger
authors: R
authors: Barker
authors: Oliver
authors: O
authors: Brüstle
authors: Elena
authors: E
authors: Cattaneo
authors: Hans
authors: H
authors: Clevers
authors: George Q
authors: GQ
authors: Daley
authors: Michele
authors: M
authors: De Luca
authors: Lawrence
authors: L
authors: Goldstein
authors: Olle
authors: O
authors: Lindvall
authors: Christine
authors: C
authors: Mummery
authors: Pamela G
authors: PG
authors: Robey
authors: Clara
authors: C
authors: Sattler de Sousa E Brito
authors: Austin
authors: A
authors: Smith
mesh_terms: D005060:Europe; D006801:Humans; D007558:Italy; D061214:Patient Safety; D033581:Stem Cell Transplantation / Q000009:adverse effects / Q000331:legislation & jurisprudence* / Q000592:standards; D013234:Stem Cells; D057170:Translational Research, Biomedical
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