Evidence map›Paper›PMID 33531267›Full record

ArticleCytotherapy2021

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

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Cytotherapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Adam JoulesDepartment of Biomedical Engineering, University of Minnesota, Minneapolis, Minnesota, USA.
Julianne ConnorsDepartment of Mechanical Engineering, University of Minnesota, Minneapolis, Minnesota, USA.
Rachel JohnsonDepartment of Biomedical Engineering, University of Minnesota, Minneapolis, Minnesota, USA.
Elizabeth A Van OrsowDepartment of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, Minnesota, USA.
David H McKennaCell Therapy Clinical Laboratory, M Health Fairview, Molecular and Cellular Therapeutics, Saint Paul, Minnesota, USA.
Sarah NikiforowDana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts, USA.
Jerome RitzDana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts, USA.
Adrian GeeCenter for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital, Houston, Texas, USA.
Allison HubelDepartment of Mechanical Engineering, University of Minnesota, Minneapolis, Minnesota, USA. Electronic address: hubel001@umn.edu.

Funding

Multicomponent solutions for the preservation of cell therapy productsR01EB023880 · NIBIB · UNIVERSITY OF MINNESOTA · PI HUBEL, ALLISON · 2017 to 2019
$1.1M
Integrated training in development and clinical practice of cell-based therapiesR25HL128372 · NHLBI · UNIVERSITY OF MINNESOTA · PI HUBEL, ALLISON, MCKENNA, DAVID HURLEY · 2015 to 2019
$553k
NHLBI NIH HHS R25 HL128372NIBIB NIH HHS R01 EB023880
6 · The paper itself

Abstract

BACKGROUND

aimsCell 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.

methodsInfusions 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.

resultsVariations 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.

conclusionsBased 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.

Indexed as

Cell- and Tissue-Based TherapyImmunotherapy, AdoptiveUnited StatesWorkflowcell therapycryopreservationinfusionstandardization

Identifiers

PMID33531267
PMCPMC9013238

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.