nctId: NCT06322394 id: BXOS110-Ⅱ-2023-12 briefTitle: BXOS110 Injection in the Treatment of Acute Ischaemic Stroke overallStatus: RECRUITING date: 2024-02-07 date: 2025-03 date: 2025-09 date: 2024-03-21 date: 2024-03-21 name: Biocells (Beijing) Biotech Co.,Ltd class: INDUSTRY briefSummary: The purpose of this study was to evaluate the effectiveness of early administration of BXOS110 for injection in reducing overall disability in patients with acute ischaemic stroke. conditions: Acute Ischemic Stroke studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 300 type: ESTIMATED name: high-dose BXOS110 name: low-dose BXOS110 name: Placebo measure: Proportion of subjects with mRS score 0-2 on day 90 measure: Proportion of subjects with mRS score 0-1 on day 90 measure: Day 90 mRS Displacement Analysis measure: Proportion of subjects with NIHSS scores ≤1 on day 10 (or at discharge) measure: Proportion of subjects with a ≥4-point reduction in NIHSS score from baseline at day 10 (or at discharge) measure: Proportion of subjects with ≥4 point increase in NIHSS score during hospitalisation measure: Proportion of subjects with Barthel Index Scale (BI) scores ≥95 on day 90 measure: Day 90 European Five Dimensional Health Scale (EQ-5D) Score measure: Mortality due to stroke within 90 days measure: Change in infarct volume from baseline after 24 hours of dosing sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yuebei People's Hospital status: NOT_YET_RECRUITING city: Shaoguan state: Guangdong country: China name: Junbin Chen role: CONTACT phone: 86-13500205898 email: cjbcl0397@163.com lat: 24.8 lon: 113.58333 facility: Harrison International Peace Hospital status: NOT_YET_RECRUITING city: Hengshui state: Hebei country: China name: Yan Wei role: CONTACT phone: 86-18003188568 email: Hayuanwy@163.com lat: 37.73222 lon: 115.70111 facility: The First Hospital of Hebei Medical University status: NOT_YET_RECRUITING city: Shijiazhuang state: Hebei country: China name: Xiaoyun Liu role: CONTACT phone: 86-13191887318 email: a331083909@126.com lat: 38.04139 lon: 114.47861 facility: Daqing Oilfield General Hospital status: NOT_YET_RECRUITING city: Daqing state: Heilongjiang country: China name: Dan Deng role: CONTACT phone: 86-18245977799 email: 707604206@qq.com lat: 46.58333 lon: 125.0 facility: Anyang People's Hospital status: NOT_YET_RECRUITING city: Anyang state: Henan country: China name: Jiangang Zhang role: CONTACT phone: 86-13513722532 email: 709705699@qq.com lat: 36.096 lon: 114.38278 facility: Nanshi Hospital of Nanyang status: NOT_YET_RECRUITING city: Nanyang state: Henan country: China name: Guang Wu role: CONTACT phone: 86-13525687571 email: seizelinni@163.com lat: 32.99472 lon: 112.53278 facility: Nanyang Second General Hospital status: NOT_YET_RECRUITING city: Nanyang state: Henan country: China name: Ming Wang role: CONTACT phone: 86-15139096969 email: 15139096969@163.com lat: 32.99472 lon: 112.53278 facility: The First Affiliated Hospital of Nanyang Medicinal College status: NOT_YET_RECRUITING city: Nanyang state: Henan country: China name: Tao Feng role: CONTACT phone: 86-15638996063 email: 631740898@qq.com lat: 32.99472 lon: 112.53278 facility: MeiHekou Central Hospital status: NOT_YET_RECRUITING city: Meihekou state: Jilin country: China name: Hong Yu role: CONTACT phone: 86-13844564195 email: 2823974848@qq.com lat: 42.52722 lon: 125.67528 facility: Beipiao Central Hospital status: RECRUITING city: Chaoyang state: Liaoning country: China name: Yutong Ma role: CONTACT phone: 86-18642143339 email: myt3339@163.com lat: 41.57028 lon: 120.45861 facility: Ceneral Hospital of Mining Industry Group Fuxin status: NOT_YET_RECRUITING city: Fuxin state: Liaoning country: China name: Yingjie Duan role: CONTACT phone: 86-13470363261 email: 451142359@qq.com lat: 42.01556 lon: 121.65889 facility: The Affiliated Hospital of Shenyang Medical College status: NOT_YET_RECRUITING city: Shenyang state: Liaoning country: China name: Runhui Li role: CONTACT phone: 86-18002477116 email: lirh710717@163.com lat: 41.79222 lon: 123.43278 facility: The First People's Hospital of Shenyang status: NOT_YET_RECRUITING city: Shenyang state: Liaoning country: China name: Tie Sui role: CONTACT phone: 86-13998352587 email: jakeyisui@icloud.com lat: 41.79222 lon: 123.43278 facility: The People's Hospital of Liaoning Province status: NOT_YET_RECRUITING city: Shenyang state: Liaoning country: China name: Qiu He role: CONTACT phone: 86-17702589222 email: qiuhe6392@sina.com lat: 41.79222 lon: 123.43278 facility: Iron Coal General Hospital of Liaoning Health Industry Group status: NOT_YET_RECRUITING city: Tieling state: Liaoning country: China name: Yu Wang role: CONTACT phone: 86-13188417658 email: fffoo@sina.com lat: 42.29306 lon: 123.84139 facility: Keshketengqi Hospital of Traditional Chinese Medicine and Mongolian Medicine status: RECRUITING city: Chifeng state: Neimenggu country: China name: Guozhi Lu role: CONTACT phone: 86-13722169555 email: gz9555@sina.com lat: 42.26833 lon: 118.96361 facility: Xianyang Hospital of Yan'an University status: NOT_YET_RECRUITING city: Xianyang state: Shaanxi country: China name: Wen Liu role: CONTACT phone: 86-18740505535 email: 174461442@qq.com lat: 34.33778 lon: 108.70261 facility: Liaocheng People's Hospital status: NOT_YET_RECRUITING city: Liaocheng state: Shandong country: China name: Cunju Guo role: CONTACT phone: 86-13346256168 email: cunjuguo@163.com lat: 36.45596 lon: 115.97766 facility: Linyi People's Hospital status: NOT_YET_RECRUITING city: Linyi state: Shandong country: China name: Ziran Wang role: CONTACT phone: 86-13954993801 email: wzr0806@163.com lat: 35.06306 lon: 118.34278 facility: Tengzhou Central People's Hospital status: NOT_YET_RECRUITING city: Tengzhou state: Shandong country: China name: Deyang Li role: CONTACT phone: 86-13561190369 email: lideyang0632@163.com lat: 35.08357 lon: 117.19071 facility: Sinopharm Tongmei General Hospital status: NOT_YET_RECRUITING city: Datong state: Shanxi country: China name: Junhai Wang role: CONTACT phone: 86-13753265757 email: wjh1964@sohu.com lat: 40.09361 lon: 113.29139 facility: Linfen Central Hospital status: RECRUITING city: Linfen state: Shanxi country: China name: Hongguo Dai role: CONTACT phone: 86-15935767592 email: daihongguo3199@163.com lat: 36.08889 lon: 111.51889 facility: Linfen People's Hospital status: NOT_YET_RECRUITING city: Linfen state: Shanxi country: China name: Junfang Hao role: CONTACT phone: 86-13835360973 email: haojunfang2012@163.com lat: 36.08889 lon: 111.51889 facility: Beijing Tiantan Hospital , Capital Medical University status: NOT_YET_RECRUITING city: Beijing country: China name: Yongjun Wang role: CONTACT phone: 86-13911172565 email: yongjunwang111@aliyun.com lat: 39.9075 lon: 116.39723 hasResults: False