Open Access
Biodistribution studies for cell therapy products: Current status and issues
Yoshiteru Kamiyama
1
,
Yoichi Naritomi
1
,
Yuu Moriya
2
,
Syunsuke Yamamoto
2
,
Tsukasa Kitahashi
3
,
Toshihiko Maekawa
3
,
Masahiro Yahata
4
,
Takeshi Hanada
5
,
Asako Uchiyama
6
,
Akari Noumaru
7
,
Yoshiyuki Koga
7
,
Tomoaki Higuchi
8
,
Masahiko Ito
9
,
Hiroyuki KOMATSU
10
,
Sosuke Miyoshi
1
,
Sadaaki Kimura
1
,
Nobuhiro UMEDA
1
,
Eriko Fujita
1
,
Naoko Tanaka
11
,
Taku Sugita
2
,
Satoru Takayama
12
,
Akihiko Kurogi
13
,
Satoshi Yasuda
14
,
YOJI SATO
14
1
Drug Discovery Research, Astellas Pharma Inc, 21, Miyukigaoka, Tsukuba, Ibaraki, Japan.
|
3
Bioscience & Engineering Laboratory, FUJIFILM Corp., 577 Ushijima, Kaisei-Machi, Ashigarakami-gun, Kanagawa, Japan
|
4
Preclinical Research Unit, Sumitomo Dainippon Pharma Co., Ltd., 3-1-98 Kasugade-naka, Konohana-ku, Osaka, Japan.
|
6
Drug Safety Research Laboratories, Shin Nippon Biomedical Laboratories, Ltd., Kagoshima, Kagoshima, Japan.
|
7
Kumamoto Laboratories, LSIM Safety Institute Corporation, 1285 Kurisaki-machi, Uto, Kumamoto, Japan.
|
8
Non-clinical Development, Axcelead Drug Discovery Partners, Inc., 26-1, Muraoka-Higashi 2-chome, Fujisawa, Kanagawa, Japan.
|
9
Tsukuba Research Institute, BoZo Research Center Inc., 8 Okubo, Tsukuba, Ibaraki, Japan.
|
10
Science BD Department, CMIC Pharma Science Co., Ltd., 1-1-1 Shibaura, Minato-ku, Tokyo, Japan.
|
11
Evaluation Center, Terumo Corporation, 1500 Inokuchi, Nakai-machi, Ashigarakami-gun, Kanagawa, Japan
|
12
Cell Therapy Technology, Healthcare R&D Center, Asahi Kasei Corporation, 2-1 Samejima, Fuji-Shi, Shizuoka, Japan
|
13
Regenerative Medicine Research & Planning Division, ROHTO Pharmaceutical Co., Ltd., Osaka, Japan.
|
Publication type: Journal Article
Publication date: 2021-12-01
scimago Q2
wos Q2
SJR: 0.881
CiteScore: 5.1
Impact factor: 3.5
ISSN: 23523204
PubMed ID:
34307798
Biomaterials
Biomedical Engineering
Developmental Biology
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.
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Total citations:
23
Citations from 2024:
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(56%)
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RIS |
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GOST
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Kamiyama Y. et al. Biodistribution studies for cell therapy products: Current status and issues // Regenerative Therapy. 2021. Vol. 18. pp. 202-216.
GOST all authors (up to 50)
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Kamiyama Y., Naritomi Y., Moriya Y., Yamamoto S., Kitahashi T., Maekawa T., Yahata M., Hanada T., Uchiyama A., Noumaru A., Koga Y., Higuchi T., Ito M., KOMATSU H., Miyoshi S., Kimura S., UMEDA N., Fujita E., Tanaka N., Sugita T., Takayama S., Kurogi A., Yasuda S., SATO Y. Biodistribution studies for cell therapy products: Current status and issues // Regenerative Therapy. 2021. Vol. 18. pp. 202-216.
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RIS
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TY - JOUR
DO - 10.1016/j.reth.2021.06.005
UR - https://doi.org/10.1016/j.reth.2021.06.005
TI - Biodistribution studies for cell therapy products: Current status and issues
T2 - Regenerative Therapy
AU - Kamiyama, Yoshiteru
AU - Naritomi, Yoichi
AU - Moriya, Yuu
AU - Yamamoto, Syunsuke
AU - Kitahashi, Tsukasa
AU - Maekawa, Toshihiko
AU - Yahata, Masahiro
AU - Hanada, Takeshi
AU - Uchiyama, Asako
AU - Noumaru, Akari
AU - Koga, Yoshiyuki
AU - Higuchi, Tomoaki
AU - Ito, Masahiko
AU - KOMATSU, Hiroyuki
AU - Miyoshi, Sosuke
AU - Kimura, Sadaaki
AU - UMEDA, Nobuhiro
AU - Fujita, Eriko
AU - Tanaka, Naoko
AU - Sugita, Taku
AU - Takayama, Satoru
AU - Kurogi, Akihiko
AU - Yasuda, Satoshi
AU - SATO, YOJI
PY - 2021
DA - 2021/12/01
PB - Japanese Society of Regenerative Medicine
SP - 202-216
VL - 18
PMID - 34307798
SN - 2352-3204
ER -
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BibTex (up to 50 authors)
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@article{2021_Kamiyama,
author = {Yoshiteru Kamiyama and Yoichi Naritomi and Yuu Moriya and Syunsuke Yamamoto and Tsukasa Kitahashi and Toshihiko Maekawa and Masahiro Yahata and Takeshi Hanada and Asako Uchiyama and Akari Noumaru and Yoshiyuki Koga and Tomoaki Higuchi and Masahiko Ito and Hiroyuki KOMATSU and Sosuke Miyoshi and Sadaaki Kimura and Nobuhiro UMEDA and Eriko Fujita and Naoko Tanaka and Taku Sugita and Satoru Takayama and Akihiko Kurogi and Satoshi Yasuda and YOJI SATO},
title = {Biodistribution studies for cell therapy products: Current status and issues},
journal = {Regenerative Therapy},
year = {2021},
volume = {18},
publisher = {Japanese Society of Regenerative Medicine},
month = {dec},
url = {https://doi.org/10.1016/j.reth.2021.06.005},
pages = {202--216},
doi = {10.1016/j.reth.2021.06.005}
}