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• W2767549602 abstract "Clinical application of autologous cells by businesses promoting unproven stem cell treatments represents the largest growth sector in this problematic industry, but also presents special challenges to regulators. Patients frequently identify autologous cells as personal property, using the language of ‘ownership’. Through an analysis of comments submitted to the US FDA in 2016 in response to recent draft guidance documents, I show that a sense of ownership and identity in autologous cells is consistently expressed by stakeholders. In the USA and other countries, regulation of cell and tissue biologics as ‘drugs’ relies substantially on whether a given product has been modified in ways that alter its biological properties, which has direct implications for property and ownership rights. Competing views on property rights in ‘natural’ and modified autologous cells have profound implications for the future of regulation of marketed autologous cells." @default.
• W2767549602 created "2017-11-17" @default.
• W2767549602 creator A5029861486 @default.
• W2767549602 date "2017-10-01" @default.
• W2767549602 modified "2023-10-02" @default.
• W2767549602 title "Identity and ownership issues in the regulation of autologous cells" @default.
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• W2767549602 doi "https://doi.org/10.2217/rme-2017-0063" @default.
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