研究者詳細 - 寺井　崇二

論文 - 寺井　崇二

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Revisiting Hepatic Fibrosis Risk in Congenital Heart Disease: Insights from Non-Invasive Markers and Echocardiography

Fusako Yamazaki, Hiroteru Kamimura, Saori Endo, Suguru Miida, Hiroki Maruyama, Tomoaki Yoshida, Masaru Kumagai, Naruhiro Kimura, Hiroyuki Abe, Akira Sakamaki, Takeshi Yokoo, Masanori Tsukada, Fujito Numano, Akihiko Saitoh, Maya Watanabe, Shuichi Shiraishi, Masanori Tsuchida, Shinya Fujiki, Takeshi Kashimura, Takayuki Inomata, Hirofumi Nonaka, Kenya Kamimura, Atsunori Tsuchiya, Shuji Terai

Children 2025年8月

門脈圧亢進関連疾患における病態と診断の未来予想図先天性心疾患術後における肝線維化有病率と心エコー所見との関連非侵襲的マーカーを用いた予測因子の検討

上村博輝, 山崎文紗子, 堀端祐介, 福島直弥, 小島雄一, 川田雄三, 冨永顕太郎, 弥久保俊太, 熊谷優, 吉田智彰, 渡邊雄介, 木村成宏, 阿部寛幸, 横尾健, 坂牧僚, 寺井崇二

日本門脈圧亢進症学会雑誌 31 ( 3 ) 114 - 114 2025年8月

Simultaneous Evaluation of Shear Wave Elastography and C-Peptide Index for Predicting Need of Insulin Therapy in Type 2 Diabetes: A Pilot Study

Moeno Sugita-Hamada, Takeshi Yokoo, Nao Nakajima, Yoshifumi Takahashi, Akihiko Osaki, Masaki Maruyama, Masaaki Takamura, Nobuo Waguri, Osamu Isokawa, Shuji Terai

Journal of Personalized Medicine 2025年7月

医療機関連携急性肝不全ネットワークを円滑に行い生体肝移植にて救命できた急性肝不全昏睡型の1例

武田信峻, 土屋淳紀, 石井結唯, 夏井一輝, 荒生祥尚, 林和直, 寺井崇二

肝臓 66 ( 7 ) 319 - 319 2025年7月

Validation of PBC-10 in Japanese patients with primary biliary cholangitis. 国際誌

Akihito Takeuchi, Masanori Abe, Sachiko Furukawa, Tadashi Namisaki, Atsushi Takahashi, Kazumichi Abe, Kentaro Kikuchi, Ryo Miura, Naoko Tachizawa, Yoshinari Asaoka, Akinobu Takaki, Yoshiyuki Ueno, Akira Honda, Shuji Terai, Atsumasa Komori, Hiromasa Ohira, Hitoshi Yoshiji, Atsuko Yonezawa, Atsushi Tanaka

Hepatology research : the official journal of the Japan Society of Hepatology 55 ( 7 ) 986 - 993 2025年7月

記述言語：英語掲載種別：研究論文（学術雑誌）

BACKGROUND AND AIM: Primary biliary cholangitis (PBC) is a chronic cholestatic liver disease that significantly impairs health-related quality of life (HRQOL). The PBC-10, a short-form HRQOL assessment tool, was developed for rapid screening in clinical settings. This study aimed to verify the reliability and validity of the Japanese version of the PBC-10 in Japanese patients with PBC. METHODS: We retrospectively analyzed HRQOL data from 496 Japanese outpatients with PBC, collected between 2015 and 2016. Reliability was assessed using Cronbach's alpha, item-total score correlations, and ceiling and floor effects. Validity was evaluated by examining correlations between PBC-10 scores and the total and subdomain scores of the Japanese version of the PBC-40, a validated PBC-specific HRQOL questionnaire. RESULTS: Cronbach's alpha for the PBC-10 was 0.872, demonstrating high internal consistency. Strong item-total score correlations were observed for all items. No ceiling effects were noted, but floor effects were present across all items. The PBC-10 total score showed a very strong positive correlation with the PBC-40 total score (ρ = 0.964, p < 0.001). Strong correlations were also found between most PBC-10 items and the PBC-40 subdomains, supporting validity. CONCLUSION: The Japanese version of the PBC-10 is a reliable and valid tool for rapidly assessing HRQOL in Japanese PBC outpatients. It has potential utility for identifying patients who may benefit from emerging treatments targeting symptom relief.

DOI： 10.1111/hepr.14199

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Machine‐Learning Prediction of Bleeding After Endoscopic Submucosal Dissection for Early Gastric Cancer: A Multicenter Study

Hiroki Maruyama, Kazuya Takahashi, Kosuke Kojima, Nao Nakajima, Hiroki Sato, Ken‐ichi Mizuno, Soichi Sugitani, Shuji Terai

JGH Open 9 ( 7 ) 2025年6月

掲載種別：研究論文（学術雑誌）出版者・発行元：Wiley

ABSTRACT

Background

Endoscopic submucosal dissection (ESD) is a minimally invasive treatment for early gastric cancer (GC); however, post‐ESD bleeding remains a serious and unpredictable complication. This study aimed to develop machine‐learning (ML) models to predict post‐ESD bleeding and identify associated risk factors, ensuring accurate and interpretable predictions.

Methods

A retrospective, multicenter clinical database was constructed for patients who underwent ESD for early GC. An ML model was developed using patient characteristics and perioperative findings to predict bleeding within 28 days post‐ESD. Its performance was compared with that of a logistic regression–based non‐ML model. Feature importance analysis was performed to aid interpretation.

Results

Among 1084 patients (median age: 75 years), post‐ESD bleeding occurred in 63 (5.8%). The area under the curve of the ML model was better than that of the non‐ML model (0.80 vs. 0.71, p = 0.03). Furthermore, the ML model demonstrated a trend toward higher sensitivity compared with the non‐ML model (0.74 vs. 0.58, p = 0.58). When stratified by ML‐estimated bleeding probability, observed bleeding rates were 2.3%, 8.8%, and 28.6% in the low‐ (< 50%), intermediate‐ (50%–80%), and high‐probability (≥ 80%) groups, respectively. The odds of bleeding were significantly higher in the intermediate‐ (OR 4.03, p = 0.03) and high‐probability (OR 16.7, p < 0.01) groups compared to the low‐probability group. Anticoagulant use with atrial fibrillation emerged as a key predictor.

Conclusions

The ML model effectively rules out post‐ESD bleeding and identifies clinically meaningful risk factors, supporting its use in personalized prophylactic strategies.

DOI： 10.1002/jgh3.70203

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Guidance on the clinical application of extracellular vesicles. 国際誌

Shuji Terai, Motohiro Asonuma, Ayuko Hoshino, Masahiro Kino-Oka, Takahiro Ochiya, Kiyoshi Okada, Yoji Sato, Yuki Takahashi, Morikuni Tobita, Atsunori Tsuchiya

Regenerative therapy 29 43 - 50 2025年6月

記述言語：英語掲載種別：研究論文（学術雑誌）

Therapies using extracellular vesicles (EVs), exosomes, or cell culture supernatants containing EVs or exosomes (referred to as "EV therapies" in this Guidance) have garnered an increasing amount of interest. However, pharmaceutical products containing EVs as their main active ingredient are yet to receive regulatory approval. The "Basic points to consider regarding the preparation of extracellular vesicles and their clinical applications in Japan," was announced by the Japanese Society for Regenerative Medicine (JSRM) on March 10, 2021, with a specific focus on exosomes among EVs to promote high safety standards in this evolving field and facilitate the application of EV clinically. The Scientific Committee of the Pharmaceuticals and Medical Devices Agency and the Japanese Society for Extracellular Vesicles have issued reports and statements regarding treatment, resulting in a growing momentum toward treatment in Japan. This article summarized the basic items that should be recognized comprehensively for clinical practice in three categories: (1) risk profiling, (2) preparation (manufacturing) process and quality, and (3) verification of EVs checking items and effectiveness. This guideline will be revised in the future with technological innovations and new findings; nevertheless, it will serve as a guide for the development of treatments.

DOI： 10.1016/j.reth.2025.02.008

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Multidirectional therapeutic effects of synthesized HMGB1 peptide on liver cirrhosis in mice. 国際誌

Masaki Mito, Atsunori Tsuchiya, Soichi Ishii, Takafumi Tonouchi, Kaito Furuyama, Ryo Jinbo, Nobutaka Takeda, Hiroyuki Abe, Katsuto Tamai, Shuji Terai

Biochemistry and biophysics reports 42 102061 - 102061 2025年6月

記述言語：英語掲載種別：研究論文（学術雑誌）

AIM: Liver cirrhosis is a serious disease characterized by liver dysfunction and severe fibrosis; however, no breakthrough drugs have effectively improved fibrosis, making it an unmet medical need. We have previously reported that the HMGB1 peptide, synthesized from box A of the HMGB1 protein, ameliorates liver fibrosis and is a promising candidate for fibrosis-improving drugs against liver cirrhosis. In this study, we used spatial analysis to observe treatment-induced changes over time. METHODS: Liver cirrhosis was induced in C57BL/6J mice using carbon tetrachloride (CCl4) injections, followed by HMGB1 peptide treatment. To assess the temporal effects of HMGB1 on the liver in a CCl4-induced cirrhosis mouse model, we used GeoMx spatial analysis. We focused on αSMA-positive active hepatic stellate cells (HSCs), F4/80-positive macrophages, and CK8/18-positive hepatocytes to determine how each cell type was affected over time. Statistical analyses were conducted using GraphPad Prism9, with significance set at p < 0.05. RESULTS: In cirrhotic mice, we first observed a decrease in the number of activated HSCs over time, two weeks after treatment initiation. Macrophage-associated genes ceased to induce fibrosis-related pathways early in the treatment. This suggests that the effect of macrophages on fibrosis was weakened by the treatment. We also confirmed that lipid metabolism of hepatocytes may be improved during treatment. Furthermore, Cxcl12 and Ccl25 expression were induced in the peptide-treated group, indicating possible cell migration to the liver. CONCLUSION: Over time, macrophages followed by HSCs, showed the most notable changes with treatment, resulting in improved fibrosis. The HMGB1 peptide drug also affected lipid metabolism in hepatocytes, suggesting a positive therapeutic effect on steatohepatitis. Elevated factors that promote cell migration may have also enhanced the healing effect.

DOI： 10.1016/j.bbrep.2025.102061

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Polygenic Risk Score for Metabolic Dysfunction-Associated Steatotic Liver Disease and Steatohepatitis: A Narrative Review. 国際誌

Tatsuo Kanda, Reina Sasaki-Tanaka, Hiroyuki Abe, Naruhiro Kimura, Tomoaki Yoshida, Kazunao Hayashi, Akira Sakamaki, Takeshi Yokoo, Hiroteru Kamimura, Atsunori Tsuchiya, Kenya Kamimura, Shuji Terai

International journal of molecular sciences 26 ( 11 ) 2025年5月

記述言語：英語掲載種別：研究論文（学術雑誌）

Metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH) are spreading worldwide as the most critical causes of cirrhosis and hepatocellular carcinoma (HCC). Thus, improving the screening and managing strategies for patients with MASLD or MASH is necessary. A traditional non-systemic review provided this narrative. Genetic variations associated with the development of MASLD and MASH, such as PNPLA3, TM6SF2, GCKR, MBOAT7, MERTK, and HSD17B13, were initially reviewed. PNPLA3 genetic variants appeared to be strongly associated with the increased pathogenesis of MASLD, MASH, cirrhosis, and HCC. We also reviewed the useful polygenic risk score (PRS) for the development of MASLD, MASH, their related cirrhosis, and the occurrence of HCC. PRSs appeared to be better predictors of MASLD, MASH, the development of cirrhosis, and the occurrence of HCC in patients with MASLD or MASH than any single-nucleotide polymorphisms. RNA interference and antisense nucleotides against the genetic variations of PNPLA3 and HSD17B13 are also being developed. Multidisciplinary collaboration and cooperation involving hepatologists, geneticists, pharmacologists, and pathologists should resolve complicated problems in MASLD and MASH. This narrative review highlights the importance of the genetic susceptibility and PRS as predictive markers and personalized medicine for patients with MASLD or MASH in the future.

DOI： 10.3390/ijms26115164

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Importance of understanding a diagnostic-treatment algorithm for primary hyperparathyroidism-induced acute pancreatitis during pregnancy. 国際誌

Kenya Kamimura, Shuji Terai

World journal of gastroenterology 31 ( 18 ) 105866 - 105866 2025年5月

記述言語：英語

In this article, we have commented on the article by Augustin et al. The authors presented a systematic review of the diagnosis, treatment, and outcomes of primary hyperparathyroidism-induced acute pancreatitis in pregnant women. Since acute pancreatitis during pregnancy could cause maternal as well as fetal adverse outcomes, understanding this pathology is essential. Although there are various etiologies of acute pancreatitis during pregnancy, primary hyperparathyroidism is one of the causes that complicate hypercalcemia. Along with conventional treatment for acute pancreatitis, parathyroidectomy can effectively normalize calcium levels and improve acute pancreatitis. Augustin et al have provided vital information that can enable physicians to understand and treat hyperparathyroidism-induced acute pancreatitis in pregnant women, which could contribute to better maternal and fetal outcomes. In addition, since primary hyperparathyroidism is associated with multiple endocrine neoplasia, further consideration regarding screening for multiple endocrine neoplasia might lead to better prognoses.

DOI： 10.3748/wjg.v31.i18.105866

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Hepatitis A and E Viruses Are Important Agents of Acute Severe Hepatitis in Asia: A Narrative Review. 国際誌

Reina Sasaki-Tanaka, Tatsuo Kanda, Takeshi Yokoo, Hiroyuki Abe, Kazunao Hayashi, Akira Sakamaki, Hiroteru Kamimura, Shuji Terai

Pathogens (Basel, Switzerland) 14 ( 5 ) 2025年5月

記述言語：英語掲載種別：研究論文（学術雑誌）

Acute-on-chronic liver failure (ACLF) and acute liver failure (ALF) are severe hepatitis that occur in patients with and without chronic liver diseases and/or cirrhosis, respectively, and both often result in death. Hepatitis A virus (HAV) and hepatitis E virus (HEV) infection can cause these severe conditions. We reviewed the role of HAV and HEV, which infect humans through the fecal-oral route, in ALF and ACLF in Asian countries. This narrative review was the derived from a traditional non-systematic review. Hepatitis A should be recognized as one of the sexually transmitted infections, especially among men who have sex with men. HAV genotype IIIA infection seems to present a more severe clinical manifestation. Acute HEV-1 infection is associated with ALF in pregnant women in India. HEV-4, rather than HEV-3, was found in severe hepatitis in Japan. HEV also plays a role as a cause of acute insult and/or chronic liver disease in immunocompromised patients with ACLF. Further studies are needed for the development of vaccines and antivirals against HAV and HEV infections. Despite the limitations of the recording of cases and the extent of specific vaccinations, multidisciplinary cooperation, involving hepatologists, virologists, experts in public health, etc., may improve the treatment of HAV and HEV infection.

DOI： 10.3390/pathogens14050454

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UC関連腫瘍術後の空置腸管にUCを再燃し、カロテグラストメチルが奏功した一例

五十嵐崇徳, 小島雄一, 登内孝文, 吉田智彰, 高橋一也, 林和直, 坂牧僚, 寺井崇二

日本消化器病学会甲信越支部例会抄録集 76回 31 - 31 2025年5月

Cholestasis in hepatitis E virus infection. 国際誌

Tatsuo Kanda, Reina Sasaki-Tanaka, Takeshi Yokoo, Kazunao Hayashi, Hiroteru Kamimura, Atsunori Tsuchiya, Shuji Terai

World journal of hepatology 17 ( 4 ) 99899 - 99899 2025年4月

記述言語：英語

Hepatitis E virus (HEV) infection causes acute hepatitis, chronic hepatitis, particularly in compromised hosts, and various extrahepatic manifestations. HEV infection is reportedly associated with biliary-pancreatic diseases, such as gallstones, cholangitis, choledocholithiasis, and acute pancreatitis. Severe jaundice and prolonged cholestasis are also atypical manifestations of HEV infection. The mechanism and genes involved in cholestasis, namely sinusoidal uptake of blood, bile salt synthesis and secretion from hepatocytes to the canaliculus, have been elucidated. HEV infection triggers severe jaundice and prolonged cholestasis in patients with genetic variants in adenosine triphosphatase phospholipid transporting 8B1, adenosine triphosphate-binding cassette (ABC) protein B4, ABCB11, Myosin VB, and/or farnesoid X receptor (FXR/NR1H4). Although prolonged cholestasis associated with these gene mutations does not seem to be specific to HEV infection, these mutations may be risk factors related to the severity of HEV infection. The use of the pregnane X receptor agonist rifampicin and the peroxisome proliferator-activated receptor activator bezafibrate may be useful for the treatment of cholestasis. These studies provide new insights into understanding the mechanisms of severe jaundice and prolonged cholestasis caused by HEV infection.

DOI： 10.4254/wjh.v17.i4.99899

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Mapping of rehabilitation interventions and assessment methods for patients with liver cirrhosis: a scoping review. 国際誌

Yuichiro Hosoi, Michiyuki Kawakami, Daisuke Ito, Takayuki Kamimoto, Hiroteru Kamimura, Takumi Kawaguchi, Shuji Terai, Tetsuya Tsuji

BMC gastroenterology 25 ( 1 ) 291 - 291 2025年4月

記述言語：英語掲載種別：研究論文（学術雑誌）

BACKGROUND: This scoping review aimed to delineate the detailed components of exercise therapy and the evaluation methods used for patients with liver cirrhosis. METHODS: The methodology involved searching the original PubMed, Web of Science, and Scopus for studies published between January 1975 and March 2025. The search was completed on 13 March 2025. Studies describing exercise therapy for liver cirrhosis patients were selected. Relevant information matching the study objectives, such as intervention duration, content, intensity setting, evaluation criteria, and outcomes, was extracted and documented. RESULTS: Of the 2314 articles identified, 18 fit the inclusion and exclusion criteria, with a total of 950 participants. The most prevalent form of exercise therapy was a combined aerobic exercise and strength training program (55.6%). Commonly used assessment criteria included the 6-minute walking distance for endurance evaluation (44.4%) and the Chronic Liver Disease Questionnaire for quality of life assessment (33.3%). Intervention durations ranged from 30 to 60 min per day, 2 to 7 days per week, and 8 to 12 weeks. Concerning intensity setting, subjective fatigue levels and heart rate were frequently used (38.9%), though detailed descriptions were limited. CONCLUSIONS: For the establishment of effective exercise therapy for patients with liver cirrhosis, future research should concentrate on tailoring intensity settings according to individual patient needs. Additionally, standardized reporting of intervention details and assessment methods is crucial for improving the quality and comparability of studies in this field.

DOI： 10.1186/s12876-025-03881-4

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Safety of edoxaban for delayed bleeding in gastrointestinal endoscopic procedures with a high risk of bleeding. 国際誌

Ken-Ichi Mizuno, Junji Yokoyama, Osamu Shibata, Yuichi Kojima, Yuzo Kawata, Kazuya Takahashi, Kentaro Tominaga, Igarashi Satoshi, Hayashi Kazunao, Shuji Terai

DEN open 5 ( 1 ) e70018 2025年4月

記述言語：英語掲載種別：研究論文（学術雑誌）

OBJECTIVES: There are limited reports on the safety of gastrointestinal endoscopic procedures in individuals taking edoxaban, one of the direct oral anticoagulants. We clarified the incidence of delayed bleeding in patients who were on edoxaban in the perioperative period of gastrointestinal endoscopic procedures with a high risk of bleeding. METHODS: This was an investigator-initiated, single-center, open-label, prospective, single-arm study. Patients on warfarin or edoxaban undergoing endoscopy with a high risk of bleeding were enrolled from June 2018 to September 2021. Warfarin was replaced with edoxaban in patients on warfarin. Patients taking other direct oral anticoagulants, and antiplatelet drugs, were excluded. The primary endpoint was severe delayed bleeding (Common Terminology Criteria for Adverse Events [CTCAE] grades III-V) and the secondary endpoints included thromboembolism, all adverse events, any delayed bleeding (CTCAE grades I or II), and hospital stay durations. RESULTS: Twenty-one patients on edoxaban underwent high-risk endoscopy. Three cases (14%) experienced CTCAE grade III delayed bleeding, requiring endoscopic hemostasis. No CTCAE grade I-II delayed bleeding or thromboembolic events occurred. Cholangitis and aspiration pneumonia (conservatively treated) occurred during the hospital stay. The median length of hospital stay was 8 days (range 3-24 days). Patients with delayed bleeding had higher systolic blood pressure at admission and longer hospital stays. CONCLUSIONS: The delayed bleeding incidence in high-risk endoscopic procedures for patients on edoxaban was acceptable. Higher blood pressure may be associated with increased risk, but further research is needed.

DOI： 10.1002/deo2.70018

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MASHモデルマウスに対する自走式回転かごによる運動負荷が肝組織や筋肉に及ぼす影響とそのメカニズム

三井田秀, 上村博輝, 丸山紘貴, 渡邉雄介, 木村成宏, 阿部寛幸, 佐々木玲奈, 横尾健, 坂牧僚, 上村顕也, 寺井崇二

肝臓 66 ( Suppl.1 ) A382 - A382 2025年4月

A型肝炎の薬剤開発現状と将来

神田達郎, 佐々木玲奈, 上村博輝, 阿部寛幸, 水戸將貴, 杉田萌乃, 荒生祥尚, 阿部聡司, 坂牧僚, 林和直, 横尾健, 上村顕也, 須田剛士, 寺井崇二

肝臓 66 ( Suppl.1 ) A362 - A362 2025年4月

Coexistence of Relapsing Polychondritis, Crohn's Disease, and Pyoderma Gangrenosum Treated Successfully with Adalimumab: A Case Report and Literature Review.

Shun Yamazaki, Kentaro Tominaga, Kotaro Watanabe, Makoto Watanabe, Shuhei Kondo, Norihiro Sakai, Tomoaki Yoshida, Yuichi Kojima, Yusuke Watanabe, Yuzo Kawata, Naruhiro Kimura, Kazuya Takahashi, Hiroki Sato, Satoshi Ikarashi, Hiroteru Kamimura, Kazunao Hayashi, Shuji Terai

Internal medicine (Tokyo, Japan) 2025年3月

記述言語：英語掲載種別：研究論文（学術雑誌）

Relapsing polychondritis (RP) is a rare, progressive, immune-mediated systemic inflammatory disease of unknown etiology characterized by recurrent inflammation of cartilaginous structures. Approximately 30% of RP cases are associated with autoimmune disease. However, co-occurrence of RP and Crohn's disease (CD) has rarely been reported. We herein report a case of coexisting RP, CD, and pyoderma gangrenosum that was successfully treated with adalimumab in combination with methotrexate. We believe that this case and literature review will facilitate the accurate and prompt diagnosis and treatment of RP combined with CD and various other complications.

DOI： 10.2169/internalmedicine.5024-24

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Current management and future perspectives of covert hepatic encephalopathy in Japan: a nationwide survey.

Takao Miwa, Mio Tsuruoka, Hajime Ueda, Tamami Abe, Hiroki Inada, Yoshimi Yukawa-Muto, Masatsugu Ohara, Taeang Arai, Yasuyuki Tamai, Hiroshi Isoda, Tomoko Tadokoro, Tatsunori Hanai, Takanori Ito, Nobuharu Tamaki, Akira Sakamaki, Yoshihiko Aoki, Fujimasa Tada, Sachiyo Yoshio, Hirokazu Takahashi, Asahiro Morishita, Tsuyoshi Ishikawa, Jun Inoue, Goki Suda, Chikara Ogawa, Masanori Atsukawa, Atsushi Hiraoka, Hidekatsu Kuroda, Tadashi Namisaki, Takashi Honda, Takumi Kawaguchi, Yasuhito Tanaka, Shuji Terai, Tadashi Ikegami, Hitoshi Yoshiji, Motoh Iwasa, Masahito Shimizu

Journal of gastroenterology 2025年3月

記述言語：英語掲載種別：研究論文（学術雑誌）

BACKGROUND: Covert hepatic encephalopathy (CHE) leads to devastating outcomes in patients with cirrhosis. This study aims to elucidate the current management and future perspectives of CHE in Japan. METHODS: A questionnaire-based cross-sectional study was conducted among physicians involved in managing cirrhosis in Japan. The primary aim was to elucidate the real-world management of CHE, including testing and treatment. Factors influencing the implementation of CHE testing were analyzed using a logistic regression model. Limitations and future perspectives for improving the management of CHE were also evaluated. RESULTS: Of 511 physicians surveyed, 93.9% recognized CHE as a significant problem, and 86.9% agreed that it should be tested. Overall, 62.8% of physicians tested for CHE, whereas 37.2% did not. Multivariable analysis identified institutional factors and certifying board as significant determinants of CHE test implementation. The Stroop (68.2%) and neuropsychiatric tests (57.5%) were the most commonly used methods of identifying CHE. Among those who tested for CHE, 87.7% treated CHE; the most common treatments were lactulose (81.5%), rifaximin (76.3%), and branched-chain amino acids (70.4%). Among non-testers, the primary barrier was the time requirement for testing. Proposals to encourage CHE testing included the development of simple tests and integration of multidisciplinary teams. CONCLUSIONS: Most physicians involved in cirrhosis care in Japan recognize CHE as a significant problem that warrants testing. However, testing for CHE remains limited by institutional factors and physician specialties. Time requirements for CHE testing are the primary barrier, and simple tests and multidisciplinary teams are recommended to enhance CHE management.

DOI： 10.1007/s00535-025-02232-0

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Targeted animal models for preclinical assessment of cellular and gene therapies in pancreatic and liver diseases: regulatory and practical insights. 国際誌

Hongjun Wang, Rachele Ciccocioppo, Shuji Terai, Sara Shoeibi, Gianluca Carnevale, Giulia De Marchi, Atsunori Tsuchiya, Soichi Ishii, Takafumi Tonouchi, Kaito Furuyama, Yuan Yang, Masaki Mito, Hiroyuki Abe, Rosanna Di Tinco, Vincenzo Cardinale

Cytotherapy 27 ( 3 ) 259 - 278 2025年3月

記述言語：英語掲載種別：研究論文（学術雑誌）

Cellular and gene therapy (CGT) products have emerged as a popular approach in regenerative medicine, showing promise in treating various pancreatic and liver diseases in numerous clinical trials. Before these therapies can be tested in human clinical trials, it is essential to evaluate their safety and efficacy in relevant animal models. Such preclinical testing is often required to obtain regulatory approval for investigational new drugs. However, there is a lack of detailed guidance on selecting appropriate animal models for CGT therapies targeting specific pancreatic and liver conditions, such as pancreatitis and chronic liver diseases. In this review, the gastrointestinal committee for the International Society for Cell and Gene Therapy provides a summary of current recommendations for animal species and disease model selection, as outlined by the US Food and Drug Administration, with references to EU EMA and Japan PMDA. We discuss a range of small and large animal models, as well as humanized models, that are suitable for preclinical testing of CGT products aimed at treating pancreatic and liver diseases. For each model, we cover the associated pathophysiology, commonly used metrics for assessing disease status, the pros and limitations of the models, and the relevance of these models to human conditions. We also summarize the use and application of humanized mouse and other animal models in evaluating the safety and efficacy of CGT products. This review aims to provide comprehensive guidance for selecting appropriate animal species and models to help bridge the gap between the preclinical research and clinical trials using CGT therapies for specific pancreatic and liver diseases.

DOI： 10.1016/j.jcyt.2024.11.008

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