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