研究者詳細 - 清水　忍

論文 - 清水　忍

分割表示 >> ／全件表示 36 件中 1 - 36 件目

Systemic administration of clinical-grade multilineage-differentiating stress-enduring cells ameliorates hypoxic–ischemic brain injury in neonatal rats. 査読有り

1. Ueda K, Sato Y, Shimizu S, Suzuki T, Onoda A, Miura R, Go S, Mimatsu H, Kitase Y, Yamashita Y, Irie K, Tsuji M, Mishima K, Mizuno M, Takahashi Y, Dezawa M, Hayakawa M.

SCIENTIFIC REPORTS 13 巻 ( 1 ) 頁： 14958 2023年9月

Mexiletine in spinal and bulbar muscular atrophy: a randomized controlled trial 査読有り国際誌

Yamada Shinichiro, Hashizume Atsushi, Hijikata Yasuhiro, Inagaki Tomonori, Ito Daisuke, Kishimoto Yoshiyuki, Kinoshita Fumie, Hirakawa Akihiro, Shimizu Shinobu, Nakamura Tomohiko, Katsuno Masahisa

ANNALS OF CLINICAL AND TRANSLATIONAL NEUROLOGY 9 巻 ( 11 ) 頁： 1702 - 1714 2022年11月

Influence of background characteristics in responders of regenerative therapy by periurethral injection of adipose-derived regenerative cells for male stress urinary incontinence 査読有り国際誌

Yamanishi Tomonori, Ishizuka Osamu, Shimizu Shinobu, Kobayashi Yumiko, Kinoshita Fumie, Yamamoto Tokunori, Mizokami Atushi, Narimoto Kazutaka, Toriyama Kazuhiro, Kamei Yuzuru, Kuwatsuka Yachiyo, Mizuno Masaaki, Gotoh Momokazu

LUTS-LOWER URINARY TRACT SYMPTOMS 14 巻 ( 4 ) 頁： 273 - 280 2022年7月

Protocol for a Phase 1, Open-Label, Multiple-Center, Dose-Escalation Study to Evaluate the Safety and Tolerability of ADR-001 in the Treatment of Immunoglobulin A Nephropathy 査読有り国際誌

Tanaka Akihito, Furuhashi Kazuhiro, Fujieda Kumiko, Maeda Kayaho, Saito Shoji, Mimura Tetsushi, Saka Yosuke, Naruse Tomohiko, Ishimoto Takuji, Kosugi Tomoki, Kinoshita Fumie, Kuwatsuka Yachiyo, Shimizu Shinobu, Nakai Yasuhiro, Maruyama Shoichi

FRONTIERS IN MEDICINE 9 巻頁： 883168 2022年5月

Safety and tolerability of a multilineage-differentiating stress-enduring cell-based product in neonatal hypoxic-ischaemic encephalopathy with therapeutic hypothermia (SHIELD trial): a clinical trial protocol open-label, non-randomised, dose-escalation trial 査読有り

Matsuyama Nao, Shimizu Shinobu, Ueda Kazuto, Suzuki Toshihiko, Suzuki Sakiko, Miura Ryosuke, Katayama Akemi, Ando Masahiko, Mizuno Masaaki, Hirakawa Akihiro, Hayakawa Masahiro, Sato Yoshiaki

BMJ OPEN 12 巻 ( 4 ) 頁： e057073 2022年4月

Survey Results and Recommendations from Japanese Stakeholders for Good Clinical Practice Renovation 査読有り

Nakamura Kenichi, Ozawa Hitoshi, Shibata Taro, Ushirozawa Nobuko, Hata Tomomi, Okita Natsuko, Fuse Nozomu, Sato Norihiro, Ikeda Koji, Hanaoka Hideki, Maruyama Tatsuya, Wada Michihiko, Shimizu Shinobu, Kasai Hiroi, Yamamoto Yoichi, Sakurai Jun, Todaka Koji, Tashiro Shimon, Yamamoto Haruko

THERAPEUTIC INNOVATION & REGULATORY SCIENCE 56 巻 ( 2 ) 頁： 220 - 229 2022年3月

Safety and efficacy of MIKE-1 in patients with advanced pancreatic cancer: a study protocol for an open-label phase I/II investigator-initiated clinical trial based on a drug repositioning approach that reprograms the tumour stroma 査読有り

Mizutani Yasuyuki, Iida Tadashi, Ohno Eizaburo, Ishikawa Takuya, Kinoshita Fumie, Kuwatsuka Yachiyo, Imai Miwa, Shimizu Shinobu, Tsuruta Toshihisa, Enomoto Atsushi, Kawashima Hiroki, Fujishiro Mitsuhiro

BMC CANCER 22 巻 ( 1 ) 頁： 205 2022年2月

Comparison of Successful and Unsuccessful Cases of New Drug Approvals Based on the International Council on Harmonization E5 Guidelines in Japan 査読有り

Asada Ryuta, Shimizu Shinobu, Nakamura Harumasa, Ono Shunsuke, Yamaguchi Takuhiro

CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT 10 巻 ( 5 ) 頁： 434 - 439 2021年5月

The evaluation of the safety and efficacy of intravenously administered allogeneic multilineage-differentiating stress-enduring cells in a swine hepatectomy model. 査読有り

Iseki M, Mizuma M, Wakao S, Kushida Y, Kudo K, Fukase M, Ishida M, Ono T, Shimura M, Ise I, Suzuki Y, Sueta T, Asada R, Shimizu S, Ueno Y, Dezawa M, Unno M

Surgery today 51 巻 ( 4 ) 頁： 634 - 650 2021年4月

Biological characterization of adipose-derived regenerative cells used for the treatment of stress urinary incontinence 査読有り

Okabe Yuka Tsukagoshi, Shimizu Shinobu, Suetake Yukihiro, Matsui-Hirai Hisako, Hasegawa Shizuka, Takanari Keisuke, Toriyama Kazuhiro, Kamei Yuzuru, Yamamoto Tokunori, Mizuno Masaaki, Gotoh Momokazu

INTERNATIONAL JOURNAL OF UROLOGY 28 巻 ( 1 ) 頁： 115 - 124 2021年1月

Intravenously delivered multilineage-differentiating stress enduring cells dampen excessive glutamate metabolism and microglial activation in experimental perinatal hypoxic ischemic encephalopathy. 査読有り国際共著

Suzuki T, Sato Y, Kushida Y, Tsuji M, Wakao S, Ueda K, Imai K, Iitani Y, Shimizu S, Hida H, Temma T, Saito S, Iida H, Mizuno M, Takahashi Y, Dezawa M, Borlongan CV, Hayakawa M

Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism 頁： 271678X20972656 2020年11月

Regenerative treatment for male stress urinary incontinence by periurethral injection of adipose-derived regenerative cells: Outcome of the ADRESU study 査読有り

Gotoh, M; Shimizu, S; Yamamoto, T; Ishizuka, O; Yamanishi, T; Mizokami, A; Narimoto, K; Toriyama, K; Kamei, Y; Nakayama, S; Kuwatsuka, Y; Mizuno, M; Hirakawa, A

INTERNATIONAL JOURNAL OF UROLOGY 27 巻 ( 10 ) 頁： 859 - 865 2020年10月

Influence of human adipose stem cells on prostate cancer cell growth 査読有り

Yamamoto, T; Gotoh, M; Koide, N; Funahashi, Y; Shimizu, S; Takei, Y

NAGOYA JOURNAL OF MEDICAL SCIENCE 82 巻 ( 2 ) 頁： 217 - 224 2020年5月

Efficacy and Safety of Rituximab in Refractory CIDP With or Without IgG4 Autoantibodies (RECIPE): Protocol for a Double-Blind, Randomized, Placebo-Controlled Clinical Trial 査読有り

Shimizu, S; Iijima, M; Fukami, Y; Tamura, N; Nakatochi, M; Ando, M; Nishi, R; Koike, H; Kaida, K; Koga, M; Kanda, T; Ogata, H; Kira, JI; Mori, M; Kuwabara, S; Katsuno, M

JMIR RESEARCH PROTOCOLS 9 巻 ( 4 ) 頁： e17117 2020年4月

Phase I study of vorinostat with gefitinib in BIM deletion polymorphism/epidermal growth factor receptor mutation double-pnositive lung cancer 査読有り国際共著

Takeuchi, S; Hase, T; Shimizu, S; Ando, M; Hata, A; Murakami, H; Kawakami, T; Nagase, K; Yoshimura, K; Fujiwara, T; Tanimoto, A; Nishiyama, A; Arai, S; Fukuda, K; Katakami, N; Takahashi, T; Hasegawa, Y; Ko, TK; Ong, ST; Yano, S

CANCER SCIENCE 111 巻 ( 2 ) 頁： 561 - 570 2020年2月

A Novel Treatment with Stem Cells from Human Exfoliated Deciduous Teeth for Hypoxic-Ischemic Encephalopathy in Neonatal Rats 査読有り

Kitase, Y; Sato, Y; Ueda, K; Suzuki, T; Mikrogeorgiou, A; Sugiyama, Y; Matsubara, K; Okabe, YT; Shimizu, S; Hirata, H; Yukawa, H; Baba, Y; Tsuji, M; Takahashi, Y; Yamamoto, A; Hayakawa, M

STEM CELLS AND DEVELOPMENT 29 巻 ( 2 ) 頁： 63 - 74 2020年1月

Src inhibition attenuates polyglutamine-mediated neuromuscular degeneration in spinal and bulbar muscular atrophy 査読有り

Iida, M; Sahashi, K; Kondo, N; Nakatsuji, H; Tohnai, G; Tsutsumi, Y; Noda, S; Murakami, A; Onodera, K; Okada, Y; Nakatochi, M; Okabe, YT; Shimizu, S; Mizuno, M; Adachi, H; Okano, H; Sobue, G; Katsuno, M

NATURE COMMUNICATIONS 10 巻 ( 1 ) 頁： 4262 2019年9月

A descriptive research: Exclusion from submitted clinical data package in the review process of new drug approval due to GCP violation in Japan 査読有り

Asada, R; Yoshimura, K; Hattori, K; Nonaka, Y; Kasai, H; Shimizu, S

CONTEMPORARY CLINICAL TRIALS COMMUNICATIONS 15 巻頁： 100416 2019年9月

Design of a Randomized Controlled Clinical Study of tissue-engineered osteogenic materials using bone marrow-derived mesenchymal cells for Maxillomandibular bone defects in Japan: the TEOM study protocol 査読有り

Shimizu, S; Tsuchiya, S; Hirakawa, A; Kato, K; Ando, M; Mizuno, M; Osugi, M; Okabe, K; Katagiri, W; Hibi, H

BMC ORAL HEALTH 19 巻 ( 1 ) 頁： 69 2019年4月

Treatment of male stress urinary incontinence using autologous adipose-derived regenerative cells: Long-term efficacy and safety 査読有り

Gotoh, M; Yamamoto, T; Shimizu, S; Matsukawa, Y; Kato, M; Majima, T; Takai, S; Funahashi, Y; Toriyama, K

INTERNATIONAL JOURNAL OF UROLOGY 26 巻 ( 3 ) 頁： 400 - 405 2019年3月

医師主導治験における標準業務手順書の適切な作成と効率的な運用に向けた検討．査読有り

林宏至，岩崎幸司，熊谷いづみ，横式沙紀，菊池佳代子，清水忍，寺町真由美，加賀山祐樹，松山琴音，笠井宏委，内山麻希子，山本学

薬理と治療 47 巻頁： s134 - s147 2019年

腹圧性尿失禁に対する治療括約筋再生

山本徳則，清水忍，後藤百万

臨床泌尿器科 73 巻 ( 2 ) 頁： 130 - 135 2019年

Phase I study of combined therapy with vorinostat and gefitinib to treat BIM deletion polymorphism-associated resistance in EGFR-mutant lung cancer (VICTROY-J)

Hase, T; Takeuchi, S; Ando, M; Hata, A; Kenmotsu, H; Fujiwara, T; Shimizu, S; Nagase, K; Yoshimura, K; Katakami, N; Takahashi, T; Hasegawa, Y; Yano, S

ANNALS OF ONCOLOGY 28 巻 2017年11月

Design of a single-arm clinical trial of regenerative therapy by periurethral injection of adipose-derived regenerative cells for male stress urinary incontinence in Japan: the ADRESU study protocol 査読有り

Shimizu, S; Yamamoto, T; Nakayama, S; Hirakawa, A; Kuwatsuka, Y; Funahashi, Y; Matsukawa, Y; Takanari, K; Toriyama, K; Kamei, Y; Narimoto, K; Yamanishi, T; Ishizuka, O; Mizuno, M; Gotoh, M

BMC UROLOGY 17 巻 ( 1 ) 頁： 89 2017年9月

Human Muse Cells, Nontumorigenic Pluripotent-Like Stem Cells, Have Liver Regeneration Capacity Through Specific Homing and Cell Replacement in a Mouse Model of Liver Fibrosis 査読有り

Iseki, M; Kushida, Y; Wakao, S; Akimoto, T; Mizuma, M; Motoi, F; Asada, R; Shimizu, S; Unno, M; Chazenbalk, G; Dezawa, M

CELL TRANSPLANTATION 26 巻 ( 5 ) 頁： 821 - 840 2017年

Phase I study of combined therapy with vorinostat and gefitinib to treat BIM deletion polymorphism-associated resistance in EGFR-mutant lung cancer (VICTROY-J): a study protocol. 査読有り

Takeuchi S, Yoshimura K, Fujiwara T, Ando M, Shimizu S, Nagase K, Hasegawa Y, Takahashi T, Katakami N, Inoue A, Yano S

The journal of medical investigation : JMI 64 巻 ( 3.4 ) 頁： 321 - 325 2017年

尿失禁に対する脂肪幹細胞が作り出す微小環境を活用した治療の開発

山本徳則，舟橋康人，松川宜久，中山忍，清水忍，後藤百万

泌尿器外科 29 巻 ( 4 ) 頁： 335-338 2016年

実用化に向けた非臨床開発の基本的考え方招待有り

清水忍

神経治療 33 巻 ( 3 ) 頁： 453-458 2016年

抗悪性腫瘍薬の臨床データパッケージ分析からみる今後の課題査読有り

平川晃弘，木下文恵，森由美子，清水忍

医薬品医療機器レギュラトリーサイエンス 46 巻 ( 10 ) 頁： 714-720 2015年

What Factors Lead to prolonged Regulatory Review Times for New Drugs in Japan? 査読有り

Yoneda S, Asada R, Shimizu S, Ono S, Yamaguchi T

J Clin Trials 5 巻 ( 6 ) 頁： 247 2015年

名古屋大学における生命倫理審査委員会の事前審査に関する状況調査査読有り

清水忍，中山忍，飯島祥彦，加藤勝義，安藤昌彦，水野正明，直江知樹

臨床薬理 44 巻 ( 6 ) 頁： 443-450 2013年11月

Analysis of new drugs whose clinical development and regulatory approval were hampered during their introduction in Japan. 査読有り

Asada R, Shimizu S, Ono S, Ito T, Shimizu A, Yamaguchi T.

J Clin Pharm Ther. 38 巻 ( 4 ) 頁： 309-313 2013年8月

記述言語：英語掲載種別：研究論文（学術雑誌）

What is known and Objective: Many drugs fail during development. However, detailed reasons for failure during drug development are almost never disclosed. We focused on the drugs whose clinical development and registration were initially hampered, but which were finally approved to identify reasons that delayed their marketing approval in Japan.
Methods: We analysed 727 new drug applications (NDAs) approved in Japan between 2001 and 2011.
Results and Discussion: Fifty-three NDAs had serious and identifiable problems during drug development. Of these, 43 NDAs had `problem related to clinical data'. We found that the problems for withdrawal of these NDAs could be ascribed largely to inappropriate clinical data package and study design for supporting the intended indications and usage and to unclear clinical results for defining dosage regimen or efficacy of the drugs.
What is new and Conclusion: Our results indicate the importance of careful determination of the optimal dosage regimen and the choice of objective endpoints in clinical trials. Further, it is important to establish a clear strategy for generating the clinical data package, to include careful design of clinical trials on the basis of the nature of the target disease and target population. For drugs marketed in Japan, there is a need to include sufficient numbers of Japanese patients in the trials.

DOI： 10.1111/jcpt.

Functional alteration of inhibitory influences on spinal motor output in painful diabetic neuropathy in rats. 査読有り

Tanabe M, Shimizu S, Takabayashi K, Honda M, Ono H.

Neurosci Lett. 389 巻 ( 3 ) 頁： 152-156 2005年12月

記述言語：英語掲載種別：研究論文（学術雑誌）

Diabetes is frequently accompanied by painful polyneuropathies that are mediated by enhanced neuronal excitability in the spinal cord, partly because of decrease in spinal intrinsic inhibitory influences. Changes in spinal excitatory-inhibitory balance may alter spinal segmental motor output. In the study presented here, the mono- and disynaptic (the fastest polysynaptic) reflexes (MSR and DSR, respectively) were recorded from L5 ventral roots in response to stimulation of the ipsilateral L5 dorsal root in spinalized streptozotocin (STZ)-induced diabetic rats with a reduced withdrawal threshold to mechanical stimuli. The diabetic rats generally exhibited larger spinal reflex amplitudes, the DSR being influenced in particular. We addressed whether recurrent and presynaptic inhibition of the spinal reflexes were altered in STZ-treated animals. The recurrent inhibition of the MSR and DSR elicited by preceding antidromic conditioning stimulation delivered to the recorded L5 ventral root was markedly suppressed in diabetic rats. By contrast, the presynaptic inhibition of the MSR and DSR elicited by preceding conditioning stimulation to the ipsilateral L4 dorsal root was not impaired. Thus, in diabetic painful neuropathy, reduced spinal intrinsic inhibition in the ventral horn contributes to an enhanced spinal segmental motor output.

Role of descending noradrenergic system and spinal α₂-adrenergic receptors in the effects of gabapentin on thermal and mechanical nociception after partial nerve injury in the mouse. 査読有り

Tanabe M, Takasu K, Kasuya N, Shimizu S, Honda M, Ono H.

Br J Pharmacol. 144 巻頁： 703-714 2005年3月

記述言語：英語掲載種別：研究論文（学術雑誌）

1. To gain further insight into the mechanisms underlying the antihyperalgesic and antiallodynic actions of gabapentin, a chronic pain model was prepared by partially ligating the sciatic nerve in mice. The mice then received systemic or local injections of gabapentin combined with either central noradrenaline (NA) depletion by 6-hydroxydopamine (6-OHDA) or α-adrenergic receptor blockade. 2. Intraperitoneally (i.p.) administered gabapentin produced antihyperalgesic and antiallodynic effects that were manifested by elevation of the withdrawal threshold to a thermal (plantar test) or mechanical (von Frey test) stimulus, respectively. 3. Similar effects were obtained in both the plantar and von Frey tests when gabapentin was injected intracerebroventricularly (i.c.v.) or intrathecally (i.t.), suggesting that it acts at both supraspinal and spinal loci. This novel supraspinal analgesic action of gabapentin was only obtained in ligated neuropathic mice, and gabapentin (i.p. and i.c.v.) did not affect acute thermal and mechanical nociception. 4. In mice in which central NA levels were depleted by 6-OHDA, the antihyperalgesic and antiallodynic effects of i.p. and i.c.v. gabapentin were strongly suppressed. 5. The antihyperalgesic and antiallodynic effects of systemic gabapentin were reduced by both systemic and i.t. administration of yohimbine, an α₂-adrenergic receptor antagonist. By contrast, prazosin (i.p. or i.t.), an α₁-adrenergic receptor antagonist, did not alter the effects of gabapentin. 6. It was concluded that the antihyperalgesic and antiallodynic effects of gabapentin are mediated substantially by the descending noradrenergic system, resulting in the activation of spinal α₂-adrenergic receptors.

DOI： 10.1038/sj.bjp.0706109

GABA_B receptors do not mediate the inhibitory actions of gabapentin on the spinal reflex in rats. 査読有り

Shimizu S, Honda M, Tanabe M, Ono H.

J Pharmacol Sci. 96 巻 ( 4 ) 頁： 444-449 2004年12月

担当区分：筆頭著者記述言語：英語掲載種別：研究論文（学術雑誌）

responsible for those actions, however, are still not clearly understood. We have recently demonstrated that gabapentin reduces the spinal reflex in rats via mechanisms that do not involve gamma-aminobutyric acid (GABA)_A receptors. In the study, we attempted to explore the involvement of GABA_B receptors in gabapentin-induced inhibition of the spinal reflexes in spinalized rats. Stimulation of the dorsal root at L5 elicited the segmental mono-(MSR) and polysynaptic reflex (PSR) in the ipsilateral ventral root. The microinjection of gabapentin (1.5 and 5 nmol) into the ventral horn reduced both MSR and PSR, whereas the injection into the dorsal horn only inhibited the PSR, indicating that systemic gabapentin inhibits the MSR at the ventral horn and it inhibits the PSR at both the ventral and dorsal horns. The GABA_B-receptor antagonist CGP35348 (0.5 nmol) injected into the ventral horn antagonized the inhibition of the spinal reflexes by the GABA_B-receptor agonist baclofen (i.v.) but not by gabapentin (i.v.). Thus, GABA_B receptors do not appear to contribute to the gabapentin-induced inhibition of the spinal reflex.

Endogenous GABA does not mediate the inhibitory effects of gabapentin on spinal reflexes in rats. 査読有り

Shimizu S, Honda M, Tanabe M, Oka J, Ono H.

J Pharmacol Sci. 94 巻 ( 2 ) 頁： 137-143 2004年2月

担当区分：筆頭著者記述言語：英語掲載種別：研究論文（学術雑誌）

The novel antiepileptic drug gabapentin was designed as a structural analog of gamma-aminobutyric acid (GABA). However, its mechanism of action remains unclear. In the present study, we investigated the effect of gabapentin on spinal reflexes in anesthetized rats. The mono- and polysynaptic reflex potentials were recorded from the ipsilateral L5 ventral root after stimulation of the L5 dorsal root. The dorsal root reflex potential, an index of presynaptic inhibition, was recorded from the ipsilateral L4 dorsal root. In non-spinalized (intact) and spinalized rats, intravenously administered gabapentin reduced the mono- and polysynaptic reflex potentials in a dose-dependent manner. These inhibitory effects of gabapentin were not suppressed by the GABA_A antagonist picrotoxin. Moreover, gabapentin also decreased spinal reflexes in spinalized rats depleted of spinal GABA with semicarbazide, an inhibitor of the GABA-synthesizing enzyme. The dorsal root reflex potentials were not affected by gabapentin. These results suggest that endogenous GABA does not mediate the inhibitory effects of gabapentin on spinal reflexes.

　前のページ - 次のページ　

<清水 忍>

論文 - 清水 忍

<清水　忍>

論文 - 清水　忍