Abstract

This manuscript is centered on novel aspects of the legislation on “Cell Therapy” through the case of a patient who underwent intrarticular treatment with an uncharacterized cellular product from which complications arose. It aims to alert the medical community that could act outside the regulations concerning advanced therapies, implying a risk of iatrogenic actions and consequent litigation processes. The commercial expansion of devices that offer cellular products without the control of the Health Administration makes it advisable to pay extreme attention to these legislative aspects.

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