Hematopoietic Cell Procurement, Processing, and Transplantation: Standards, Accreditation, and Regulation

Phyllis I. Warkentin, Elizabeth J. Shpall

Research output: Chapter in Book/Report/Conference proceedingChapter

1 Scopus citations

Abstract

Hematopoietic cells obtained from bone marrow, peripheral blood, and placental and umbilical cord blood cells are common graft sources derived from autologous, related, or unrelated donors. Rapid evolution of cellular therapies has heightened concern about the safety, purity, potency, and efficacy of cellular products. Under the authority of the Public Health Services Act and the Federal Food, Drug, and Cosmetic Act, the government, through the Food and Drug Administration (FDA), is empowered to enact binding legislation related to cellular therapy products. Some states in the U.S., such as New York, have adopted specific regulations for processing of and storage facilities for HCT/Ps. Others like, Massachusetts and Maryland, require accreditation by the Foundation for the Accreditation of Cellular Therapy (FACT) to perform hematopoietic cell transplantation within those states. All FACT Standards are developed by consensus of world-renowned experts active in cellular therapy.

Original languageEnglish (US)
Title of host publicationThomas' Hematopoietic Cell Transplantation
Subtitle of host publicationFifth Edition
PublisherWiley-Blackwell
Pages414-424
Number of pages11
Volume1-2
ISBN (Electronic)9781118416426
ISBN (Print)9781118416006
DOIs
StatePublished - Jan 1 2016

Keywords

  • Cord blood cells
  • FACT
  • Food and Drug Administration
  • Governmental regulation
  • Hematopoietic cells

ASJC Scopus subject areas

  • Medicine(all)

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    Warkentin, P. I., & Shpall, E. J. (2016). Hematopoietic Cell Procurement, Processing, and Transplantation: Standards, Accreditation, and Regulation. In Thomas' Hematopoietic Cell Transplantation: Fifth Edition (Vol. 1-2, pp. 414-424). Wiley-Blackwell. https://doi.org/10.1002/9781118416426.ch36