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细胞治疗产品的生物分布研究：现状与问题

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

作者信息

Kamiyama Yoshiteru, Naritomi Yoichi, Moriya Yuu, Yamamoto Syunsuke, Kitahashi Tsukasa, Maekawa Toshihiko, Yahata Masahiro, Hanada Takeshi, Uchiyama Asako, Noumaru Akari, Koga Yoshiyuki, Higuchi Tomoaki, Ito Masahiko, Komatsu Hiroyuki, Miyoshi Sosuke, Kimura Sadaaki, Umeda Nobuhiro, Fujita Eriko, Tanaka Naoko, Sugita Taku, Takayama Satoru, Kurogi Akihiko, Yasuda Satoshi, Sato Yoji

机构信息

Drug Discovery Research, Astellas Pharma Inc., 21 Miyukigaoka, Tsukuba, Ibaraki, Japan.

Research, Takeda Pharmaceutical Company Limited, 26-1, Muraoka-Higashi 2-chome, Fujisawa, Kanagawa, Japan.

出版信息

Regen Ther. 2021 Jul 12;18:202-216. doi: 10.1016/j.reth.2021.06.005. eCollection 2021 Dec.

DOI:10.1016/j.reth.2021.06.005
PMID:34307798
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8282960/
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.

摘要

细胞治疗产品（CTP）的生物分布（BD）信息对于预测和评估其在非临床和临床研究中的疗效及毒性特征至关重要。要开展BD研究，有必要了解监管要求、实施现状及分析方法。本综述旨在调查国际和日本关于CTP的BD研究的趋势，并对以下被认为特别重要的主题进行了调查：1）比较指南以了解全球范围内BD研究的监管状况；2）利用数据库对BD研究进行案例分析以了解其在细胞治疗中的现状；3）主要用于CTP非临床BD研究的定量聚合酶链反应（qPCR）的案例分析；4）对用于非临床和临床BD研究的成像方法的调查。本综述的结果将为实施BD研究提供有用的参考资源。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/46ba/8282960/73c93c7b9225/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/46ba/8282960/06ec30e30226/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/46ba/8282960/f1bec015bb4a/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/46ba/8282960/73c93c7b9225/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/46ba/8282960/06ec30e30226/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/46ba/8282960/f1bec015bb4a/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/46ba/8282960/73c93c7b9225/gr3.jpg

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本文引用的文献

[1]
Tumorigenicity assessment of cell therapy products: The need for global consensus and points to consider.

Cytotherapy. 2019-11-9

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EJNMMI Res. 2018-12-13

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Biodistribution and retention of locally administered human mesenchymal stromal cells: Quantitative polymerase chain reaction-based detection of human DNA in murine organs.

Cytotherapy. 2017-3

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