Evidence map›Paper›PMID 38085197›Full record

ArticleCytotherapy2024

Assessment and comparison of viability assays for cellular products.

Yihua Cai, Michaela Prochazkova, Yong-Soo Kim, Chunjie Jiang, Jinxia Ma, Larry Moses, Kathryn Martin, Victoria Pham, Nan Zhang, Steven L Highfill and 3 more

Open access · hybridAbstract read
In one paragraph

Article in Cytotherapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
6.7field-weighted citation impact, top 3% of its field
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

21 citing papers in PubMed, 29 citations in OpenAlex.

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  20. EmergentInfection and immunity · 2024
    Article
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

13 authors at 1 institution in 1 country.

Yihua CaiCenter for Cellular Engineering, Department of Transfusion Medicine, National Institutes of Health Clinical Center, Bethesda, Maryland, USA.
Michaela ProchazkovaCenter for Cellular Engineering, Department of Transfusion Medicine, National Institutes of Health Clinical Center, Bethesda, Maryland, USA.
Yong-Soo KimCenter for Cellular Engineering, Department of Transfusion Medicine, National Institutes of Health Clinical Center, Bethesda, Maryland, USA.
Chunjie JiangCenter for Cellular Engineering, Department of Transfusion Medicine, National Institutes of Health Clinical Center, Bethesda, Maryland, USA.
Jinxia MaCenter for Cellular Engineering, Department of Transfusion Medicine, National Institutes of Health Clinical Center, Bethesda, Maryland, USA.
Larry MosesCenter for Cellular Engineering, Department of Transfusion Medicine, National Institutes of Health Clinical Center, Bethesda, Maryland, USA.
Kathryn MartinCenter for Cellular Engineering, Department of Transfusion Medicine, National Institutes of Health Clinical Center, Bethesda, Maryland, USA.
Victoria PhamCenter for Cellular Engineering, Department of Transfusion Medicine, National Institutes of Health Clinical Center, Bethesda, Maryland, USA.
Nan ZhangCenter for Cellular Engineering, Department of Transfusion Medicine, National Institutes of Health Clinical Center, Bethesda, Maryland, USA.
Steven L HighfillCenter for Cellular Engineering, Department of Transfusion Medicine, National Institutes of Health Clinical Center, Bethesda, Maryland, USA.
Robert P SomervilleCenter for Cellular Engineering, Department of Transfusion Medicine, National Institutes of Health Clinical Center, Bethesda, Maryland, USA.
David F StroncekCenter for Cellular Engineering, Department of Transfusion Medicine, National Institutes of Health Clinical Center, Bethesda, Maryland, USA.
Ping JinCenter for Cellular Engineering, Department of Transfusion Medicine, National Institutes of Health Clinical Center, Bethesda, Maryland, USA. Electronic address: pjin@mail.cc.nih.gov.
National Institutes of Health Clinical Center · US

Funding

Intramural NIH HHS Z99 CL999999
6 · The paper itself

Abstract

BACKGROUND

aimsAccurate assessment of cell viability is crucial in cellular product manufacturing, yet selecting the appropriate viability assay presents challenges due to various factors. This study compares and evaluates different viability assays on fresh and cryopreserved cellular products, including peripheral blood stem cell (PBSC) and peripheral blood mononuclear cell (PBMC) apheresis products, purified PBMCs and cultured chimeric antigen receptor and T-cell receptor-engineered T-cell products.

methodsViability assays, including manual Trypan Blue exclusion, flow cytometry-based assays using 7-aminoactinomycin D (7-AAD) or propidium iodide (PI) direct staining or cell surface marker staining in conjunction with 7-AAD, Cellometer (Nexcelom Bioscience LLC, Lawrence, MA, USA) Acridine Orange/PI staining and Vi-CELL BLU Cell Viability Analyzer (Beckman Coulter, Inc, Brea, CA, USA), were evaluated. A viability standard was established using live and dead cell mixtures to assess the accuracy of these assays. Furthermore, precision assessment was conducted to determine the reproducibility of the viability assays. Additionally, the viability of individual cell populations from cryopreserved PBSC and PBMC apheresis products was examined.

resultsAll methods provided accurate viability measurements and generated consistent and reproducible viability data. The assessed viability assays were demonstrated to be reliable alternatives when evaluating the viability of fresh cellular products. However, cryopreserved products exhibited variability among the tested assays. Additionally, analyzing the viability of each subset of the cryopreserved PBSC and PBMC apheresis products revealed that T cells and granulocytes were more susceptible to the freeze-thaw process, showing decreased viability.

conclusionsThe study demonstrates the importance of careful assay selection, validation and standardization, particularly for assessing the viability of cryopreserved products. Given the complexity of cellular products, choosing a fit-for-purpose viability assay is essential.

Indexed as

Leukocytes, MononuclearTrypan BlueCell SurvivalCryopreservationFlow CytometryReproducibility of ResultsTrypan Bluecell countingcellular productsviabilityviability assays

Identifiers

PMID38085197
PMCPMC10872314
OpenAlexW4389537464

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.