Biodistribution studies for cell therapy products: Current status and issues

• Main Authors: Yoshiteru Kamiyama, Yoichi Naritomi, Yuu Moriya, Syunsuke Yamamoto, Tsukasa Kitahashi, Toshihiko Maekawa, Masahiro Yahata, Takeshi Hanada, Asako Uchiyama, Akari Noumaru, Yoshiyuki Koga, Tomoaki Higuchi, Masahiko Ito, Hiroyuki Komatsu, Sosuke Miyoshi, Sadaaki Kimura, Nobuhiro Umeda, Eriko Fujita, Naoko Tanaka, Taku Sugita, Satoru Takayama, Akihiko Kurogi, Satoshi Yasuda, Yoji Sato
• Format: Article
• Language: English
• Published: Elsevier 2021-12-01
• Series: Regenerative Therapy
• Subjects: Biodistribution; Cell therapy product; qPCR; Imaging; PET; SPECT
• Online Access: http://www.sciencedirect.com/science/article/pii/S235232042100050X

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.