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Journal Article
Review
Off-label use of adipose-derived stem cells.
Annals of Medicine and Surgery 2017 December
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.
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.
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