Clinical use of adipose-derived stem cells: European legislative issues

With this study we analyse the current European legislation in order to provide guidance for regenerative medicine professionals on correct Adipose-derived Stem Cells (ASCs) isolation and use protocols for clinical applications.

The European Medicines Agency (EMA) considers that ASCs does not fall within the definition of an advanced therapy medicinal product if the cells have not been subjected to a substantial manipulation, and the mode of action of the cells (contribute to and enhance tissue renewal and turnover of the subcutaneous tissue) is considered to be homologous to the donor fat tissue.

Collagenase digestion, as well as cell culturing, is considered to be a substantial manipulation. Only transplantation of a non-manipulated tissue to another location in the same anatomical or histological environment is considered to be homologous.

According to these considerations, ASCs should be not-cultured, isolated mechanically and used only in the subcutaneous tissue.