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Review
. 2019 Oct;33(5):839-855.
doi: 10.1016/j.hoc.2019.05.008. Epub 2019 Jul 30.

Current and Future Cell Therapy Standards and Guidelines

J Wade Atkins  1 , Kamille West  2 , Kimberly A Kasow  3
Affiliations
Review

Current and Future Cell Therapy Standards and Guidelines

J Wade Atkins et al. Hematol Oncol Clin North Am. 2019 Oct.

Abstract

Cell biology researchers, cellular engineers, and clinicians are teaming together to create powerful drugs. The use of cell-derived products as biologics is rapidly advancing. These human cell-based products have great potential for treating serious conditions but may have unidentified risks. Manipulations, expansions, and gene modifications increase the risks of unexpected outcomes. Implementation of the 21st Century Cures Act is opening avenues for accelerated approvals of these drugs for use in clinical trials and licensure. Although overwhelming, collaboration between regulators, industry, and research and medical communities enables the field to safely meet the needs of critically ill patients.

Keywords: Biologic drug products; Cellular therapies; HCT/Ps; Licensure requirements; PHS 351 and 361.

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