Ozeki, Michio
Tanaka, Akira
Kuniyeda, Kanako
Nozaki, Taiki
Fujino, Akihiro
Nomura, Tadashi
Uemura, Naoto
Suenobu, Souichi
Aramaki-Hattori, Noriko
Hayashi, Ayato
Kato, Aiko
Kiyosue, Hiro
Imagawa, Kotaro
Nagao, Munetomo
Shimizu, Fumiaki
Ochi, Junko
Horiuchi, Saya
Ohyama, Tetsuji
Ando, Haruhi
Nagabukuro, Hiroshi
Funding for this research was provided by:
The Japan Agency for Medical Research and Development (JP 21nk0101222)
ARTham Therapeutics Inc.
Article History
Received: 28 May 2024
Accepted: 18 January 2025
First Online: 10 February 2025
Declarations
:
: The study protocol, amendments, subject-informed consent and informed assent were approved by the independent institutional review board of each study site (Gifu University Hospital, National Center for Child Health and Development, Kobe University Hospital, Oita University Hospital, Keio University Hospital, Juntendo Urayasu Hospital, Tohoku University Hospital, and Tokai University Hospital). After having been explained the clinical trial by the investigator or sub-investigator, signed informed consent was obtained either from participants (age ≥ 20), participants and their parent/guardian (20 > age ≥ 16), or participants’ parent/guardian (age < 16). Children 7 to 15 years of age provided written informed assent.
: Written informed consent was obtained from the patient for publication of this article and any accompanying images.
: AT, KK, and HA were employees of ARTham Therapeutics Inc. and HN was the CEO of ARTham Therapeutics. MO, Tai N, AF, Tad N, NU, JO, SH, and TO served as paid adviser to ARTham Therapeutics Inc. Tai N serves as a paid adviser to Kaken Pharmaceutical Co. Ltd. AF has received honoraria from Nobelpharma Co. Ltd.