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Page 1
Accelerating Cell Therapy for Stroke in Japan: Regulatory Framework and Guidelines on Development of Cell-Based Products.
Houkin K, Shichinohe H, Abe K, Arato T, Dezawa M, Honmou O, Horie N, Katayama Y, Kudo K, Kuroda S, Matsuyama T, Miyai I, Nagata I, Niizuma K, Sakushima K, Sasaki M, Sato N, Sawanobori K, Suda S, Taguchi A, Tominaga T, Yamamoto H, Yamashita T, Yoshimine T; Working Group for Guidelines on Development of Cell-Based Products for the Treatment of Cerebral Infarction. Houkin K, et al. Among authors: arato t. Stroke. 2018 Apr;49(4):e145-e152. doi: 10.1161/STROKEAHA.117.019216. Epub 2018 Mar 16. Stroke. 2018. PMID: 29581346 Review. No abstract available.
Quality, safety and efficacy of follow-on biologics in Japan.
Yamaguchi T, Arato T. Yamaguchi T, et al. Among authors: arato t. Biologicals. 2011 Sep;39(5):328-32. doi: 10.1016/j.biologicals.2011.06.015. Epub 2011 Sep 3. Biologicals. 2011. PMID: 21890377 Free article. Review.
Protocol for treating lumbar spinal canal stenosis with a combination of ultrapurified, allogenic bone marrow-derived mesenchymal stem cells and in situ-forming gel: a multicentre, prospective, double-blind randomised controlled trial.
Sudo H, Miyakoshi T, Watanabe Y, Ito YM, Kahata K, Tha KK, Yokota N, Kato H, Terada T, Iwasaki N, Arato T, Sato N, Isoe T. Sudo H, et al. Among authors: arato t. BMJ Open. 2023 Feb 2;13(2):e065476. doi: 10.1136/bmjopen-2022-065476. BMJ Open. 2023. PMID: 36731929 Free PMC article.
Considerations of the Japanese Research Working Group for the ICH S6 & Related Issues Regarding Nonclinical Safety Assessments of Oligonucleotide Therapeutics: Comparison with Those of Biopharmaceuticals.
Hirabayashi Y, Maki K, Kinoshita K, Nakazawa T, Obika S, Naota M, Watanabe K, Suzuki M, Arato T, Fujisaka A, Fueki O, Ito K, Onodera H. Hirabayashi Y, et al. Among authors: arato t. Nucleic Acid Ther. 2021 Apr;31(2):114-125. doi: 10.1089/nat.2020.0879. Epub 2021 Jan 19. Nucleic Acid Ther. 2021. PMID: 33470890 Free PMC article.
16 results