Other cell therapy ‘products’
There are also cell therapy ‘products’ that do not fulfill the definition of an ATMP. Scientific research aimed at the development of cell therapy with a ‘product’ that does not fulfill the definition of an ATMP, also needs to be reviewed by CCMO. According to CCMO, ‘cell therapy’ should be interpreted as therapy using nucleated cells. Research using such products does not fall under the scope of research with a medicinal product.
A few examples of such products are:
- (Stem)cells derived from bone marrow or umbilical cord blood (used for stem cell transplantation) (when the definition of an ATMP has not been fulfilled);
- White blood cells from blood for example after stem cell mobilization or donor lymphocytes infusion (when the definition of an ATMP has not been fulfilled);
- Cell-containing tissues or cell-containing tissue fractions, such as stromal vascular fraction (SVF), that do not fulfill the definition of an ATMP, and are not intended to be used for ’regular’ transplantation.