Cell-based treatments: advanced therapies and transplants

The introduction of Regulation 1394/2007/EC managing the use of tissue engineering products for the purpose of repairing, regenerating, or replacing missing tissue and cells has created a gray area where transplant and medicinal products overlap. The classification of such borderline products depends on the European Medicines Agency at the moment of marketing application. However, when these products first enter into the clinical development, the burden of definition falls on National competent authorities. The concept of "minimal manipulation" and of "heterologous use" are introduced to describe currently used criteria.