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On May 6th 2014, the European Court of Human Rights added yet a new element to the judicial history of stem cells as it ruled in Durisotto v. Italy [appeal n. 62804/13]. The ruling rejected a patient claim to access an unproven cell therapy-an outcome that is certainly to be welcomed. However, this ruling is a missed occasion to clarify and reaffirm some important legal distinctions that could have greatly benefited the whole field of regenerative medicine. We claim that the ethical and political assumptions that sustain the regulation of expanded access programs to new therapies should be carefully scrutinized, with particular attention to the justifications for the risks connected to unconventional therapies. A clear legal definition of what counts as compassionate cure as distinct from unregulated and untested therapies cannot be provided unless those points are previously addressed.

Europe is ready to deploy its immense capital of knowledge into the development of effective cell-based therapies and delve into the global race for translating stem cell science into regenerative medicine. But what are the challenges and the emerging issues that lay ahead the realization of Europe's enormous potential in this field? Both researchers and industrial stakeholders tend to impute the slow pace of translation to specific suboptimal features of the regulatory environment in Europe. At the same time, a host of new issues are emerging as testified by a recent public controversy regarding the provision of unproven cell therapy in Italy. We will review this topic and suggest some solutions to foster the responsible development of innovative cell-based therapies in Europe.