Abstract
To advance xenotransplantation into the clinic relies on (i) an appropriate clinical development plan that includes a robust preclinical program, (ii) the development of suitable animal herds, and (iii) a clinical trial design with built-in protections for the xenograft recipient and the public. The potential public health risks can be mitigated by appropriate animal husbandry that includes (i) animals bred from closed herds of known origin, (ii) maintenance of animal health, and (iii) facility maintenance. Potential physiologic incompatibilities between pig and human need to be investigated as soon as possible before the trial is initiated. When possible, first-in-human studies should be conducted in individuals who can understand and consent to the study procedures and risks and thus should exclude children. For those planning a clinical trial, early consultation with the FDA is recommended.
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Abbreviations
- FDA:
-
US Food and Drug Administration
References
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Acknowledgment
The authors would like to acknowledge Dr. Allen Wensky, FDA, CBER, Office of Tissues and Advanced Therapies (OTAT), and Dr. Marc Cavaille-Coll, FDA, CDER, Office of New Drugs, for their critical review of this manuscript.
Disclosures
Winson Tang coauthored this manuscript during his tenure as a Medical Officer at the FDA, Center for Biologics Evaluation and Research, OTAT. Judith Arcidiacono is an International Regulatory Expert and the lead for policy on xenotransplantation at FDA/CBER/OTAT.
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Tang, W.W., Arcidiacono, J. (2020). Xenotransplantation: The FDA Perspective. In: Cooper, D.K.C., Byrne, G. (eds) Clinical Xenotransplantation. Springer, Cham. https://doi.org/10.1007/978-3-030-49127-7_19
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DOI: https://doi.org/10.1007/978-3-030-49127-7_19
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