Abstract
Cell therapy can be defined as the in vivo use of autologous, allogeneic or xenogeneic cells for the prevention, treatment or attenuation of disease. The definition of cell therapy products has been the source of a recent controversy in France. Presently, cell therapy is associated with biological products and manufacturing processes which are frequently poorly defined. A stringent evaluation of cell therapy, as well as the establishment of an optimal regulatory environment, are therefore justified. In France, a recent law (05.28.96) defines cell therapy products as biological products with therapeutic purpose. Cell therapy centers will receive an agreement from the Health Ministry. The French Drug Agency will have responsibility for clinical protocol approval and monitoring, as well as ensure overall quality control. Hopefully, these decisions will contribute to the emergence of cell therapy as a well established, high quality, therapeutic procedure.
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