Regulation of adult stem cells and tissue regeneration
There is an established and successful history of using adult stem cells and tissue engineered constructs in applications such as bone marrow transplantation and artificial heart valves.
Recently, new regulatory mechanisms have been introduced at the European level.
EU Tissues and Cells Directive
The EU Tissues and Cells Directive creates a common framework that ensures high standards in the procurement, testing, processing, storage, distribution and import / export of tissues and cells.
The Directive applies to all tissues and cells including haematopoietic peripheral blood, umbilical-cord (blood) and bone-marrow derived stem cells, reproductive cells (eggs, sperm) and adult and embryonic stem cells.
At the same time, it is also clear in stating that it does not apply to research. "Only those cells and tissues that in clinical trials are applied to the human body should comply with the quality and safety standards laid down in this Directive." (Recital 11)
For further considerations of doing research on tissues and cells click here.
EU Advanced therapy regulations
Regulation (EC) No 1394/2007 on advanced therapy medicinal products will apply from 30th December 2008.
Advanced therapy medicinal products are new medical products based on genes (gene therapy), cells (cell therapy) and tissues (tissue engineering).
Click here to read the NESCI response to a consultation by the Commission on draft amendments to Annex I to Directive 2001/83/EC as regards advanced therapy medicinal products.
