Abstract
Regenerative medicine is at present in a stage of development of clinical trials in cell therapies (CT), their manufacture and gradual adoption by health systems. However, there are several gaps and contradictions in governance and regulation in the area and the main aim of this article is their discussion within global trends, as these processes remain still ill- resolved while substantively affecting collective global health. The text focuses on an analysis of prevailing processes in clinical trials with CT by two leading actors, the United Kingdom, and the European Union, and is based upon bibliographical and content analyses. The article concludes with a discussion of the main advantages and disadvantages for collective global health of the transition from a conventional scientific model to test the new therapies to, eventually, one based on medical or clinical innovation. The latter proceeds from the pre-clinical research phase with animals to clinical trials with small groups of patients and subsequently, to the entrance of cell therapies into the market. Often this model is associated to flexible regulations, to be illustrated in the article, which are specifically designed to diminish time-lags between therapy development and its full application.
Keywords:
cellular therapy; clinical trials; governance; international policies; regenerative medicine; flexible regulation