- 著者
- Osanai Toshiya Houkin Kiyohiro Uchiyama Shinichiro Minematsu Kazuo Taguchi Akihiko Terasaka Shunsuke
- 出版者
- SAGE Publications
- 雑誌
- International journal of stroke (ISSN:17474930)
- 巻号頁・発行日
- vol.13, no.4, pp.444-448, 2018-06-01
- 被引用文献数
- 16
Rationale: MultiStem® (HLM051) is one of the promising allogenic cell products for acute ischemic stroke with strong evidence. A previous phase 2 randomized, double-blind, placebo-controlled, multicenter dose-escalation trial showed the safety of MultiStem® for acute ischemic stroke, with a time window beyond that of rt-PA and endovascular thrombectomy. We aim to obtain stronger evidence and to show the efficacy of the MultiStem® for treatment of ischemic stroke. Sample size: Estimated sample size is 220 (110 patients per group), which has 90% power at 5% significance level. Methods and design: TREASURE is a randomized, double-blind, placebo-controlled, multicenter phase 2/3 trial. The trial will be done at 31 medical centers in Japan. Patients with acute ischemic stroke including motor or speech deficit defined by a National Institution of Health Stroke Scale (NIHSS) score of 8-20 at baseline will be randomized 1:1 to receive a single intravenous infusion of MultiStem® or placebo within 18-36 h of stroke onset. Study outcomes: Primary outcome in this study is the proportion of patients with an excellent outcome at day 90 defined by the functional assessment. Trial registration: ClinicalTrials.gov (NCT02961504). Conclusion: The TREASURE trial will provide a novel treatment option and expand the therapeutic window for patients with stroke if the results are positive.
- 著者
- Furukawa Koji Abumiya Takeo Sakai Keiji Hirano Miki Osanai Toshiya Shichinohe Hideo Nakayama Naoki Kazumata Ken Hida Kazutoshi Houkin Kiyohiro
- 出版者
- Elsevier
- 雑誌
- Journal of Stroke and Cerebrovascular Diseases (ISSN:10523057)
- 巻号頁・発行日
- vol.25, no.11, pp.2762-2769, 2016-11
- 被引用文献数
- 50
Background and Purpose: High blood viscosity causes blood stagnation and subsequent pathological thrombotic events, resulting in the development of ischemic stroke. We hypothesize that the contribution of blood viscosity may differ among ischemic stroke subtypes based on specific pathological conditions. We tried to verify this hypothesis by measuring blood viscosity in acute ischemic stroke patients using a newly developed electromagnetic spinning sphere (EMS) viscometer. Methods: Measurements in acute ischemic stroke patients were performed 4 times during admission and data were compared with those obtained from 100 healthy outpatient volunteers. Results: We enrolled 92 patients (cardioembolism [CE]: 25, large-artery atherosclerosis [LAA]: 42, and small artery occlusion [SAO]: 25) in this study. Comparisons of blood viscosity between the ischemic stroke subgroups and control group revealed that blood viscosity at the date of admission was significantly higher in the SAO group (5.37±1.11 mPa・s) than in the control group (4.66±0.72 mPa・s) (p<0.01). Among all subtype groups showing a reduction in blood viscosity after 2 weeks, the SAO group showed the highest and most significant reduction, indicating that SAO patients had the most concentrated blood at the onset. Conclusions: Blood viscosity was significantly increased in the SAO group at the date of admission, which indicated the contribution of dehydration to the onset of ischemic stroke. The importance of dehydration needs to be emphasized more in the pathogenesis of SAO. The clinical application of the EMS viscometer is promising for understanding and differentiating the pathogenesis of ischemic stroke.