Europe's advanced therapy medicinal products: chances and challenges.

摘要

Regenerative medicine emerged in the early to mid-1990s and holds the promise of treating many serious and disabling diseases by replacing damaged, lost or diseased tissues and organs. Among the numerous applications are heart muscle repair following a myocardial infarction [1], treatment of neurodegenerative disorders including Parkinson's disease [2], enhancing wound repair and replacing damaged bone and cartilage. In the last 10 years, research has been translated into early clinical trials and the results have been quite encouraging [3]. Today, 20% of the medicines on the market and 50% of those in development are biotech-based products [101]. The potential impact of regenerative therapies is foreseen to radically change healthcare; however, it also challenges existing perceptions, dynamics and standards relating to ethics, safety and governance.