Abstract
Cellular therapies have moved to the forefront based upon promising results from clinical trials using both chimeric antigen receptor T lymphocytes to treat leukemia and other cell types to restore structure and function to tissues that have been damaged by disease or physical injury. The pace at which these treatments have evolved has posed a regulatory challenge to agencies, such as the Food and Drug Administration (FDA). This chapter describes how a specific regulatory strategy was developed and how it has evolved in response to the demand for these new therapies.
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Acknowledgments
This work was supported in part by the Cancer Prevention and Research Institute of Texas (CPRIT) Core Grant Number 3300017409. The author wishes to thank colleagues at the Center for Cell and Gene Therapy, Baylor College of Medicine, Houston, Texas.
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Gee, A.P. (2018). Regulation of Regenerative Medicine Products. In: Schmuck, E., Hematti, P., Raval, A. (eds) Cardiac Extracellular Matrix. Advances in Experimental Medicine and Biology, vol 1098. Springer, Cham. https://doi.org/10.1007/978-3-319-97421-7_10
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DOI: https://doi.org/10.1007/978-3-319-97421-7_10
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