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Exploratory clinical trial on the safety and capability of dMD-001 in lumbar disc herniation: Study protocol for a first-in-human pilot study.
Yamada K, Kenichiro M, Ito YM, Inage F, Isoe T, Yokota N, Sugita O, Sato N, Tha KK, Iwasaki N, Arato T, Sudo H. Yamada K, et al. Among authors: arato t. Contemp Clin Trials Commun. 2021 Jun 29;23:100805. doi: 10.1016/j.conctc.2021.100805. eCollection 2021 Sep. Contemp Clin Trials Commun. 2021. PMID: 34278043 Free PMC article.
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.
Research on advanced intervention using novel bone marrOW stem cell (RAINBOW): a study protocol for a phase I, open-label, uncontrolled, dose-response trial of autologous bone marrow stromal cell transplantation in patients with acute ischemic stroke.
Shichinohe H, Kawabori M, Iijima H, Teramoto T, Abumiya T, Nakayama N, Kazumata K, Terasaka S, Arato T, Houkin K. Shichinohe H, et al. Among authors: arato t. BMC Neurol. 2017 Sep 8;17(1):179. doi: 10.1186/s12883-017-0955-6. BMC Neurol. 2017. PMID: 28886699 Free PMC article. Clinical Trial.
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.
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.
A comparative study of monosaccharide composition analysis as a carbohydrate test for biopharmaceuticals.
Harazono A, Kobayashi T, Kawasaki N, Itoh S, Tada M, Hashii N, Ishii A, Arato T, Yanagihara S, Yagi Y, Koga A, Tsuda Y, Kimura M, Sakita M, Kitamura S, Yamaguchi H, Mimura H, Murata Y, Hamazume Y, Sato T, Natsuka S, Kakehi K, Kinoshita M, Watanabe S, Yamaguchi T. Harazono A, et al. Among authors: arato t. Biologicals. 2011 May;39(3):171-80. doi: 10.1016/j.biologicals.2011.04.002. Epub 2011 May 5. Biologicals. 2011. PMID: 21549615
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