Identity and ownership issues in the regulation of autologous cells.

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 Through an analysis of comments submitted to the US FDA in 2016 in response to recent draft guidance documents, I show that a sense of ownership and identity in autologous cells is consistently expressed by stakeholders.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.

journal_name

Regen Med

journal_title

Regenerative medicine

authors

Sipp D

doi

10.2217/rme-2017-0063

subject

Has Abstract

pub_date

2017-10-01 00:00:00

pages

827-838

issue

7

eissn

1746-0751

issn

1746-076X

journal_volume

12

pub_type

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