Current and Future Cell Therapy Standards and Guidelines.

Autor:	Atkins JW; 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., West K; Blood Services, Department of Transfusion Medicine, Clinical Center, NIH, 10 Center Drive, MSC-1184, Building 10, Room 1C/711E, Bethesda, MD 20892-1184, USA., Kasow KA; Department of Pediatrics, University of North Carolina, 1108 Physicians Office Building, 170 Manning, Drive, CB 7236, Chapel Hill, NC 27599-7236, USA.
Jazyk:	angličtina
Zdroj:	Hematology/oncology clinics of North America [Hematol Oncol Clin North Am] 2019 Oct; Vol. 33 (5), pp. 839-855. Date of Electronic Publication: 2019 Jul 30.
DOI:	10.1016/j.hoc.2019.05.008
Abstrakt:	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. (Published by Elsevier Inc.)
Databáze:	MEDLINE
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