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

2013; Springer Nature; Volume: 32; Issue: 11 Linguagem: Inglês

10.1038/emboj.2013.114

1460-2075

Paolo Bianco, Roger A. Barker, Oliver Brüstle, Elena Cattaneo, Hans Clevers, George Q. Daley, Michele De Luca, Lawrence S.B. Goldstein, Olle Lindvall, Christine L. Mummery, Pamela Gehron Robey, Clara Sattler de Sousa e Brito, Austin Smith,

Pluripotent Stem Cells Research

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.