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Authors
Umezawa, Akihiro
Fukuda, Akinari
Horikawa, Reiko
Uchida, Hajime
Enosawa, Shin
Oishi, Yoshie
Nakamura, Naoko
Sasaki, Kengo
Yanagi, Yusuke
Shimizu, Seiichi
Nakao, Toshimasa
Kodama, Tasuku
Sakamoto, Seisuke
Hayakawa, Itaru
Akiyama, Saeko
Saku, Noriaki
Miyata, Shoko
Ite, Kenta
Javaregowda, Palaksha Kanive
Toyoda, Masashi
Nonaka, Hidenori
Nakamura, Kazuaki
Ito, Yoshikazu
Fukuhara, Yasuyuki
Miyazaki, Osamu
Nosaka, Shunsuke
Nakabayashi, Kazuhiko
Haga, Chizuko
Yoshioka, Takako
Masuda, Akira
Ohkura, Takashi
Yamazaki-Inoue, Mayu
Machida, Masakazu
Abutani-Sakamoto, Rie
Miyajima, Shoko
Akutsu, Hidenori
Matsubara, Yoichi
Igarashi, Takashi
Kasahara, Mureo
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Funding
Funding for this research was provided by:
Japan Science and Technology Agency
AMED (JP16bk0104054, JP19bk0104088, JP22bk0104150, JP15bm0504007)
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Article History
Received: 23 August 2024
Accepted: 21 January 2025
First Online: 6 March 2025
Declarations
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: The animal experiments were approved by The Experimental Animal Committee of the National Center for Child Health and Development Research Institute (Tokyo, JAPAN) on November 24, 2016 (study title: "The Preclinical Study of ESC-Derived Regenerative Medical Products (HAES) with Ammonia Metabolism Ability," reference number: A2016-008). The protocol of the trial was formally approved by the institutional review board of the National Center for Child Health and Development on April 28, 2018 (study title: "Clinical study of HAES transplantation in patients with neonatal onset urea cycle disorder (HAES transplantation study in patients with neonatal onset urea cycle disorder)," reference number: C29007). As the subjects of this clinical trial were neonates and infants, informed consent was obtained in accordance with ethical standards. Specifically, informed consent for participation in the trial was obtained after thoroughly explaining the study to the surrogate (parents or legal guardians).
: Informed consent for publication in the trial was obtained after thoroughly explaining the study to the surrogate (parents or legal guardians).
: AU is a stockholder of iHaes, a biotechnology company focusing on stem cells and regenerative medicine. SE and TO are involved in manufacturing and sales for iHaes. The other authors declare that they have no conflicts of interest.
