The process of developing new and complex stem-cell-based therapeutics is incremental and requires decades of sustained collaboration among different stakeholders. In this Perspective, we address key ethical and policy challenges confronting the clinical translation of stem-cell-based interventions (SCBIs), including premature diffusion of SCBIs to clinical practice, assessment of risk in trials, obtaining valid informed consent for research participants, balanced and complete scientific reporting and public communications, regulation, and equitable access to treatment. We propose a way forward for translating these therapies with the above challenges in mind.
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We thank D. Sipp for helpful feedback on a draft of this manuscript; faults remain our own. We acknowledge the contributions of many scholars whose work we were unable to cite. This work was funded by CIHR grant PJT-148726.
J.K. serves on a Data and Safety Monitoring Board in a remunerative capacity for Ultragenyx Inc. The trial involves a gene therapy (not a stem-cell-based intervention). Compensation is <10K USD/year.
Editor recognition: Hannah Stower was the primary editor on this Perspective and managed its editorial process and peer review in collaboration with the rest of the editorial team.
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