Comparative analysis of cell therapy infusion workflows at clinical sites

Adam Joules, Julianne Connors, Rachel Johnson, Elizabeth A. Van Orsow, David H. McKenna, Sarah Nikiforow, Jerome Ritz, Adrian Gee, Allison Hubel

Research output: Contribution to journalArticlepeer-review

Abstract

Background aims: Cell therapies are an emerging treatment option for a variety of diseases, especially with the success of chimeric antigen receptor T-cell therapies. With 18 FDA-approved cell therapy products as of December 2020 and a growing number in clinical trials, standards for most aspects of the cell therapy lifecycle are well-established by professional organizations like AABB and FACT; however, there are limited standardized protocols regarding the day-of infusion. Methods: Infusions were observed at three academic medical centers in the United States, and the workflows were analyzed and compared based on factors including facility layout, product verification processes, cryobag design, timing restrictions, and use of electronic medical records. Results: Variations between the facilities were identified with product thawing location and cell therapy lab location being the most important factors in time from thaw to infusion. Conclusions: Based on this analysis, opportunities were identified for standardization and streamlining the infusion workflow which may help facilitate adoption of new and existing cell therapies at a wider range of hospitals.

Original languageEnglish (US)
Pages (from-to)285-292
Number of pages8
JournalCytotherapy
Volume23
Issue number4
DOIs
StatePublished - Apr 1 2021

Bibliographical note

Funding Information:
Research reported in this publication was supported by the National Institutes of Health (R01EB023880 and R25HL128372). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Publisher Copyright:
© 2021 International Society for Cell & Gene Therapy

Keywords

  • cell therapy
  • cryopreservation
  • infusion
  • standardization

PubMed: MeSH publication types

  • Journal Article
  • Research Support, N.I.H., Extramural

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