Off-label use of adipose-derived stem cells

Background: Adipose-derived stem cells (ASCs) have a broad range of clinical applications. The ease of cell harvest and high yield with minimal donor-site morbidity makes adipose tissue an ideal source of stem cells. Further, the multi-lineage potential of these cells present significant opportunities within the field of tissue engineering, with studies successfully demonstrating their ability to produce a range of tissue types. Materials and methods: Literature review of publications on the use of ASCs, in the context of current European and US regulations. Results: According to European and US regulations, many clinical trials reported in literature to date could be considered off-label. Conclusion: In Europe, clinical trials involving cultured ASCs and/or the use of collagenase, which causes changes in the structural and functional properties of stem cells, and/or ASCs application in non-homologous tissue, should be considered off-label. ASCs should be non-cultured, isolated mechanically, and used only in the subcutaneous tissue. HIGHLIGHTS Adipose-derived stem cells hold enormous potential in different fields of regenerative medicine and stem cell therapy. According to European and US regulations, many clinical trials reported in literature could be considered off-label. In Europe, ASCs should be non-cultured, isolated mechanically, and used only in the subcutaneous tissue.