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

Phyllis Irene Warkentin, Elizabeth J. Shpall

Research output: Chapter in Book/Report/Conference proceedingChapter

1 Citation (Scopus)

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

Fingerprint

Accreditation
Transplantation
Drug Legislation
Therapeutics
Unrelated Donors
United States Public Health Service
Cell Transplantation
United States Food and Drug Administration
Fetal Blood
Legislation
Bone Marrow Cells
Blood Cells
Transplants
Safety

Keywords

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

ASJC Scopus subject areas

  • Medicine(all)

Cite this

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

Hematopoietic Cell Procurement, Processing, and Transplantation : Standards, Accreditation, and Regulation. / Warkentin, Phyllis Irene; Shpall, Elizabeth J.

Thomas' Hematopoietic Cell Transplantation: Fifth Edition. Vol. 1-2 Wiley-Blackwell, 2016. p. 414-424.

Research output: Chapter in Book/Report/Conference proceedingChapter

Warkentin, PI & Shpall, EJ 2016, Hematopoietic Cell Procurement, Processing, and Transplantation: Standards, Accreditation, and Regulation. in Thomas' Hematopoietic Cell Transplantation: Fifth Edition. vol. 1-2, Wiley-Blackwell, pp. 414-424. https://doi.org/10.1002/9781118416426.ch36
Warkentin PI, Shpall EJ. Hematopoietic Cell Procurement, Processing, and Transplantation: Standards, Accreditation, and Regulation. In Thomas' Hematopoietic Cell Transplantation: Fifth Edition. Vol. 1-2. Wiley-Blackwell. 2016. p. 414-424 https://doi.org/10.1002/9781118416426.ch36
Warkentin, Phyllis Irene ; Shpall, Elizabeth J. / Hematopoietic Cell Procurement, Processing, and Transplantation : Standards, Accreditation, and Regulation. Thomas' Hematopoietic Cell Transplantation: Fifth Edition. Vol. 1-2 Wiley-Blackwell, 2016. pp. 414-424
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