Working definition

As a serice to the field, the CCMO has drafted a working definition for cell therapy research, which goes further than the definitions of cellular medicinal products for advanced therapies. The definition is as follows:

‘Cell therapy research is understood to mean the administration of human (autologous or allogenic) or xenogenic living, nucleated cells to humans, in situations in which the isolation, processing and/or administration involves individual living cells and where (processing and/or administration of) the cells are the subject of the research question.’ (unofficial translation)

According to this working definition, studies in which somatic and/or germ line cells are administered to research subjects are both considered to be cell therapy. The transplantation of tissues (with the exception of tissues consisting of loose cells, such as bone marrow) or organs is not considered to be cell therapy, unless the individual cells are processed individually without direct interaction (cell-cell contact or cell-matrix contact) prior to administration. This means that clinical research with stem cells harvested from bone marrow for haematological conditions is also covered by the definition for cell therapy, and must be reviewed by the CCMO.