Current and Future Cell Therapy Standards and Guidelines

doi:10.1016/j.hoc.2019.05.008

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 Atkins¹, Kamille West², Kimberly A Kasow³

Affiliations

¹ Department of Transfusion Medicine, Clinical Center, NIH, 10 Center Drive, MSC-1184, Building 10, Room 1C/711B, Bethesda, MD 20892-1184, USA. Electronic address: jatkins@cc.nih.gov.
² Blood Services, Department of Transfusion Medicine, Clinical Center, NIH, 10 Center Drive, MSC-1184, Building 10, Room 1C/711E, Bethesda, MD 20892-1184, USA.
³ Department of Pediatrics, University of North Carolina, 1108 Physicians Office Building, 170 Manning, Drive, CB 7236, Chapel Hill, NC 27599-7236, USA.

PMID: 31466608
DOI: 10.1016/j.hoc.2019.05.008

Review

Current and Future Cell Therapy Standards and Guidelines

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

. 2019 Oct;33(5):839-855.

doi: 10.1016/j.hoc.2019.05.008. Epub 2019 Jul 30.

Authors

J Wade Atkins¹, Kamille West², Kimberly A Kasow³

Affiliations

¹ Department of Transfusion Medicine, Clinical Center, NIH, 10 Center Drive, MSC-1184, Building 10, Room 1C/711B, Bethesda, MD 20892-1184, USA. Electronic address: jatkins@cc.nih.gov.
² Blood Services, Department of Transfusion Medicine, Clinical Center, NIH, 10 Center Drive, MSC-1184, Building 10, Room 1C/711E, Bethesda, MD 20892-1184, USA.
³ Department of Pediatrics, University of North Carolina, 1108 Physicians Office Building, 170 Manning, Drive, CB 7236, Chapel Hill, NC 27599-7236, USA.

PMID: 31466608
DOI: 10.1016/j.hoc.2019.05.008

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.

Published by Elsevier Inc.

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Current and Future Cell Therapy Standards and Guidelines

Affiliations

Current and Future Cell Therapy Standards and Guidelines

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