Allowing Innovative Stem Cell-Based Therapies outside of Clinical Trials: Ethical and Policy Challenges

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This critique also assumes too narrow of a view. Interventions that are not FDA-approved might still be offered overseas, and to shrug off any further discussion of stem cell-based innovative therapies based on current FDA standards would be to advance a U.S.-centric response to the international problem of stem cell tourism, much of which involves American patients traveling abroad. The question of whether and how to regulate stem cell-based innovative therapies is an issue for all countries, not just the U.S. Furthermore, as I argue in this section, the thorny issues raised in this essay cannot be resolved simply by depending on current American regulations.

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