Evidence map›Paper›PMID 34307798›Full record

ReviewRegenerative therapy2021

Biodistribution studies for cell therapy products: Current status and issues.

Yoshiteru Kamiyama, Yoichi Naritomi, Yuu Moriya, Syunsuke Yamamoto, Tsukasa Kitahashi, Toshihiko Maekawa, Masahiro Yahata, Takeshi Hanada, Asako Uchiyama, Akari Noumaru and 14 more

Abstract readReview
In one paragraph

Review in Regenerative therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing 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

15 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Article
  5. Receptor-Mediated SPION Labeling of CD4Nanomaterials (Basel, Switzerland) · 2025
    Article
  6. Article
  7. Review
  8. Article
  9. Article
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  11. Review
  12. Article
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  14. Review
  15. 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

24 authors.

Yoshiteru KamiyamaDrug Discovery Research, Astellas Pharma Inc., 21 Miyukigaoka, Tsukuba, Ibaraki, Japan.
Yoichi NaritomiDrug Discovery Research, Astellas Pharma Inc., 21 Miyukigaoka, Tsukuba, Ibaraki, Japan.
Yuu MoriyaResearch, Takeda Pharmaceutical Company Limited, 26-1, Muraoka-Higashi 2-chome, Fujisawa, Kanagawa, Japan.
Syunsuke YamamotoResearch, Takeda Pharmaceutical Company Limited, 26-1, Muraoka-Higashi 2-chome, Fujisawa, Kanagawa, Japan.
Tsukasa KitahashiBioscience & Engineering Laboratory, FUJIFILM Corp., 577 Ushijima, Kaisei-Machi, Ashigarakami-gun, Kanagawa, Japan.
Toshihiko MaekawaBioscience & Engineering Laboratory, FUJIFILM Corp., 577 Ushijima, Kaisei-Machi, Ashigarakami-gun, Kanagawa, Japan.
Masahiro YahataPreclinical Research Unit, Sumitomo Dainippon Pharma Co., Ltd., 3-1-98 Kasugade-naka, Konohana-ku, Osaka, Japan.
Takeshi HanadaDrug Metabolism & Pharmacokinetics Research Laboratories, Daiichi Sankyo.Co., Ltd., 1-2-58, Hiromachi, Shinagawa-ku, Tokyo, Japan.
Asako UchiyamaDrug Safety Research Laboratories, Shin Nippon Biomedical Laboratories, Ltd., Kagoshima, Kagoshima, Japan.
Akari NoumaruKumamoto Laboratories, LSIM Safety Institute Corporation, 1285 Kurisaki-machi, Uto, Kumamoto, Japan.
Yoshiyuki KogaKumamoto Laboratories, LSIM Safety Institute Corporation, 1285 Kurisaki-machi, Uto, Kumamoto, Japan.
Tomoaki HiguchiNon-clinical Development, Axcelead Drug Discovery Partners, Inc., 26-1, Muraoka-Higashi 2-chome, Fujisawa, Kanagawa, Japan.
Masahiko ItoTsukuba Research Institute, BoZo Research Center Inc., 8 Okubo, Tsukuba, Ibaraki, Japan.
Hiroyuki KomatsuScience BD Department, CMIC Pharma Science Co., Ltd., 1-1-1 Shibaura, Minato-ku, Tokyo, Japan.
Sosuke MiyoshiDrug Discovery Research, Astellas Pharma Inc., 21 Miyukigaoka, Tsukuba, Ibaraki, Japan.
Sadaaki KimuraDrug Discovery Research, Astellas Pharma Inc., 21 Miyukigaoka, Tsukuba, Ibaraki, Japan.
Nobuhiro UmedaDrug Discovery Research, Astellas Pharma Inc., 21 Miyukigaoka, Tsukuba, Ibaraki, Japan.
Eriko FujitaDrug Discovery Research, Astellas Pharma Inc., 21 Miyukigaoka, Tsukuba, Ibaraki, Japan.
Naoko TanakaEvaluation Center, Terumo Corporation, 1500 Inokuchi, Nakai-machi, Ashigarakami-gun, Kanagawa, Japan.
Taku SugitaResearch, Takeda Pharmaceutical Company Limited, 26-1, Muraoka-Higashi 2-chome, Fujisawa, Kanagawa, Japan.
Satoru TakayamaCell Therapy Technology, Healthcare R&D Center, Asahi Kasei Corporation, 2-1 Samejima, Fuji-Shi, Shizuoka, Japan.
Akihiko KurogiRegenerative Medicine Research & Planning Division, ROHTO Pharmaceutical Co., Ltd., Osaka, Japan.
Satoshi YasudaDivision of Cell-Based Therapeutic Products, National Institute of Health Sciences, 3-25-26 Tonomachi, Kawasaki-ku, Kawasaki, Kanagawa, Japan.
Yoji SatoDivision of Cell-Based Therapeutic Products, National Institute of Health Sciences, 3-25-26 Tonomachi, Kawasaki-ku, Kawasaki, Kanagawa, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Information on the biodistribution (BD) of cell therapy products (CTPs) is essential for prediction and assessment of their efficacy and toxicity profiles in non-clinical and clinical studies. To conduct BD studies, it is necessary to understand regulatory requirements, implementation status, and analytical methods. This review aimed at surveying international and Japanese trends concerning the BD study for CTPs and the following subjects were investigated, which were considered particularly important: 1) comparison of guidelines to understand the regulatory status of BD studies in a global setting; 2) case studies of the BD study using databases to understand its current status in cell therapy; 3) case studies on quantitative polymerase chain reaction (qPCR) used primarily in non-clinical BD studies for CTPs; and 4) survey of imaging methods used for non-clinical and clinical BD studies. The results in this review will be a useful resource for implementing BD studies.

Indexed as

BiodistributionCell therapy productImagingMRIPETqPCRSPECT

Identifiers

PMID34307798
PMCPMC8282960

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.