Evidence map›Paper›PMID 38983832›Full record

ArticleRegenerative therapy2024

Multisite studies for optimization of a highly efficient culture assay used for

Takeshi Watanabe, Satoshi Yasuda, Shinji Kusakawa, Takuya Kuroda, Hatsue Furukawa, Mayumi Futamura, Shigekazu Shimizu, Akihiko Morishita, Shinko Hata, Akiko Koeda and 2 more

Abstract read
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In one paragraph

Article in Regenerative therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. 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

12 authors.

Takeshi WatanabeDrug Safety Research and Evaluation, Takeda Pharmaceutical Company Limited, Kanagawa, Japan.
Satoshi YasudaDivision of Cell-Based Therapeutic Products, National Institute of Health Sciences, Kanagawa, Japan.
Shinji KusakawaDivision of Cell-Based Therapeutic Products, National Institute of Health Sciences, Kanagawa, Japan.
Takuya KurodaDivision of Cell-Based Therapeutic Products, National Institute of Health Sciences, Kanagawa, Japan.
Hatsue FurukawaSafety Business Unit, Axcelead Drug Discovery Partners, Inc., Kanagawa, Japan.
Mayumi FutamuraDrug Discovery Support Division, Tsukuba Research Institute, BoZo Research Center Inc., Ibaraki, Japan.
Shigekazu ShimizuCMIC Bioresearch Center, CMIC Pharma Science Co., Ltd., Yamanashi, Japan.
Akihiko MorishitaIg-M Co. Ltd, Hyogo, Japan.
Shinko HataIg-M Co. Ltd, Hyogo, Japan.
Akiko KoedaResearch Administration Department, Ina Research Inc., Nagano, Japan.
Kana KomatsuClinical Laboratory Department, Ina Research Inc., Nagano, Japan.
Yoji SatoDivision of Cell-Based Therapeutic Products, National Institute of Health Sciences, Kanagawa, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: MEASURE2 (Multisite Evaluation Study on Analytical Methods for Non-clinical Safety Assessment of HUman-derived REgenerative Medical Products 2) is a Japanese experimental public-private partnership initiative that aims to standardize testing methods for tumorigenicity evaluation of human pluripotent stem cell (hPSC)-derived cell therapy products (CTPs). MEASURE2 organized multisite studies to optimize the methodology of the highly efficient culture (HEC) assay, a sensitive culture-based Methods: In these multisite studies, 1) the efficiency of colony formation by human induced pluripotent stem cells (hiPSCs) under two different culture conditions and 2) the sorting efficiency of microbeads conjugated to various anti-hPSC markers during hiPSC enrichment were evaluated using samples in which hiPSCs were spiked into hiPSC-derived mesenchymal stem cells. Results: The efficiency of colony formation was significantly higher under culture conditions with the combination of Chroman 1, Emricasan, Polyamines, and Trans-ISRIB (CEPT) than with Y-27632, which is widely used for the survival of hPSCs. Between-laboratory variance was also smaller under the condition with CEPT than with Y-27632. The sorting efficiency of microbeads conjugated with the anti-Tra-1-60 antibody was sufficiently higher (>80%) than those of the other various microbeads investigated. Conclusions: Results of these multisite studies are expected to contribute to improvements in the sensitivity and robustness of the HEC assay, as well as to the future standardization of the tumorigenicity risk assessment of hPSC-derived CTPs.

Indexed as

Cell therapy productsDetection sensitivityIn vitro tumorigenicity assayMultisite studyResidual pluripotent stem cellStandardization

Identifiers

PMID38983832
PMCPMC11231703

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