[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"yilong Wang\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":147},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,43,74,95,122],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100632533","early-phase-1-the-study-of-safety-and-preliminary-efficacy-of-alt001-in-patients-with-multiple-system-atrophy-cerebellar-type-100632533",false,"NCT07514923","The Study of Safety and Preliminary Efficacy of ALT001 in Patients With MultIple System Atrophy-Cerebellar Type","SPRITE-C","Inclusion Criteria:\n\n* 1\\. Age between 30 and 75 years inclusive, either sex;\n* 2\\. Clinically established or clinically probable MSA-C as defined by the 2022 MDS diagnostic criteria for multiple system atrophy;\n* 3\\. Duration of MSA-C-related motor symptoms, including ataxia, no longer than 5 years;\n* 4\\. Score ≤ 3 on Item 14 of the Unified Multiple System Atrophy Rating Scale (UMSARS) Part II (motor examination);\n* 5\\. Estimated life expectancy ≥ 1 year as assessed by the investigator;\n* 6\\. Voluntary participation in this study and provision of written informed consent\n\nExclusion Criteria:\n\n* 1\\. Presence of other diseases that may cause ataxia at screening (e.g., infectious diseases, immune-mediated diseases, tumors, paraneoplastic conditions, hereditary disorders, trauma, nutritional deficiencies, toxic exposure, or other neurodegenerative diseases);\n* 2\\. Dementia indicated by the Mini-Mental State Examination (MMSE) at enrollment (score ≤17 for illiterate individuals, ≤20 for primary school education, or ≤24 for junior high school or above) or a prior definitive diagnosis of dementia;\n* 3\\. Evidence of other central nervous system pathologies on brain MRI at screening suggesting a diagnosis of neurodegenerative diseases other than MSA; or other significant pathological findings on brain MRI at screening, including but not limited to: cerebral hemorrhage, acute cerebral infarction, aneurysm, vascular malformation, infectious lesions, brain tumors, or other space-occupying lesions (meningiomas or arachnoid cysts with a maximum diameter \\\u003C1 cm do not require exclusion);\n* 4\\. Presence of immune-mediated diseases that are inadequately controlled or require treatment with biologic agents;\n* 5\\. Known history of allergies to biologic agents, such as proteins or cell-based products;\n* 6\\. Receipt of any vaccination within the past 1 month;\n* 7\\. Patients with a prior definitive diagnosis of malignancy or those currently receiving anti-tumor drug therapy;\n* 8\\. Patients with a prior definitive diagnosis of epilepsy or those currently taking anti-epileptic drugs;\n* 9\\. Presence of lumbar spine diseases or deformities, or other contraindications to lumbar puncture;\n* 10\\. Coagulation abnormalities at enrollment (e.g., platelet count \\\u003C100 × 10⁹\u002FL; prothrombin time \\[PT\\] \\>3 seconds), a prior diagnosis of coagulation disorders such as hemophilia, or current use of two or more antiplatelet agents;\n* 11\\. Contraindications to MRI (e.g., claustrophobia, implanted cardiac pacemaker, or ferromagnetic metal);\n* 12\\. Concurrent severe hepatic insufficiency, renal insufficiency, or severe cardiac insufficiency (severe hepatic insufficiency defined as ALT ≥1.5 times the upper limit of normal or AST ≥1.5 times the upper limit of normal; severe renal insufficiency defined as serum creatinine \\[CRE\\] ≥1.5 times the upper limit of normal or estimated glomerular filtration rate \\[eGFR\\] \\\u003C40 mL\u002Fmin\u002F1.73 m²; severe cardiac insufficiency defined as NYHA class 3-4), or any significant abnormalities on physical examination, vital signs, laboratory tests, or electrocardiogram that, in the investigator's opinion, require further examination or treatment, or may interfere with the study procedures or safety;\n* 13\\. Active hepatitis B infection (positive for hepatitis B surface antigen, recurrent\u002Fpersistent ALT elevation, positive serum HBV DNA, or serum HBV DNA \\>2 × 10⁵ IU\u002FmL);\n* 14\\. Positive for hepatitis C virus antibody or a history of positive test results;\n* 15\\. Positive for HIV or a history of positive test results;\n* 16\\. Patients with a history of alcohol or substance abuse, or alcohol or substance dependence within the past 2 years;\n* 17\\. Diagnosis of psychiatric disorders, severe anxiety, severe depression, or obvious suicidal ideation according to DSM-V diagnostic criteria;\n* 18\\. Patients who are pregnant, lactating, or have the potential to become pregnant, or those planning a pregnancy;\n* 19\\. Current participation in other interventional trials or use of other investigational biologic agents, drugs, or devices, or use of other investigational drugs within the past 1 month or within 5 half-lives of the drug;\n* 20\\. Inability to comply with follow-up assessments due to other reasons;\n* 21\\. Patients deemed by the investigator to be unsuitable for participation in this study.","ALL","30 Years","75 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","This is a single-center, prospective, randomized, open-label, blinded outcome assessment (PROBE) study. At the end of the PROBE study, patients who have completed the study may opt to enter the open-label extension (OLE) study. The objective of the study is to evaluate the safety, tolerability and potential preliminary efficacy of ALT001 in the treatment of patients with multiple system atrophy-cerebellar type (MSA-C).",[27],"Multiple System Atrophy - Cerebellar Subtype (MSA-C)",[29],"Multiple system atrophy","NOT_YET_RECRUITING","2026-03-31",{"date":33,"type":34},"2026-04-07","ACTUAL",{"date":36,"type":21},"2026-04-06",{"date":38,"type":21},"2027-10-30",{"name":40,"class":41},"yilong Wang","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":42},"100632535","the-feasibility-and-safety-of-rk-4-injection-bypassing-blood-brain-barrier-in-the-treatment-of-acute-large-hemispheric-infarction-using-intracalvariosseous-injection-device-100632535","NCT07514949","The Feasibility and Safety of RK-4 Injection Bypassing Blood-brain Barrier in the Treatment of Acute Large Hemispheric Infarction Using Intracalvariosseous Injection Device","SOLUTION-ICD","Inclusion Criteria:\n\n* 18≤Age≤80 years;\n* First stroke or complete self-care before the onset of current stroke (mRS 0-1);\n* Administration of drugs can be completed within 24h of the onset of signs and symptoms of neurological deficits (in patients with wake-up strokes or unwitnessed strokes, the time of onset is defined as the time of last normal presentation);\n* Clinical symptoms, signs and imaging diagnosis of cerebral infarction in the area supplied by the middle cerebral artery, together with the following features:\n\n  1. 16≤ NIHSS ≤32 points, and the sum of the scores of motor arm and motor leg is ≥6;\n  2. Imaging suggestive of core infarct area: apparent diffusion coefficient (ADC) values \\\u003C620×10-6mm2\u002Fs lesion volume on magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI) sequences or cerebral blood flow (CBF) \\\u003C30% of volume 70-300 ml on computed tomography perfusion imaging (CTP) or an Alberta Stroke Program Early CT Score (ASPECTS) of 0-6, with inconsistent findings, the investigator is required to make a reasoned judgement by taking into account all the information (scanning time, the imaging method that best responds to the size of infarct, etc.) and record it.\n* NIHSS score not improving or progressing after reperfusion therapy and total score still ≤32.\n* Informed consent signed.\n\nExclusion Criteria:\n\n* Complications with other cerebrovascular diseases meet one of the following conditions:\n\n  1. Complicated with acute cerebral hemorrhage and subarachnoid hemorrhage;\n  2. Complicated with acute posterior circulation cerebral infarction or severe posterior circulation stenosis (\\>70%);\n  3. Or imaging suggests that the area of cerebral infarction is involved bilaterally;\n  4. The cause of the TOAST classification was considered as intracranial artery dissection, vasculitis, moyamoya disease and other etiological types.\n* Hemorrhage transformation in the infarction area, hematoma area ≥30% of the infarction area, and has obvious space-occupying effect;\n* Presence of clinical signs of brain herniation formation, e.g., unilateral or bilateral pupil dilation and fixation; cerebral oedema-associated loss of consciousness (NIHSS 1a \\> 2 points), or other loss of brainstem reflexes in the judgement of the investigator, caused by cerebral oedema or cerebral herniation formation; or other signs of instability of vital signs that are difficult to control;\n* Craniotomy decompression was planned before randomization;\n* Refractory hypertension (systolic \\> 200mmHg or diastolic \\> 110mmHg) or hypotension (systolic \\\u003C 70mmHg or diastolic \\\u003C 50mmHg) that is difficult to control with medication;\n* Abnormal blood glucose before randomization (random venous blood glucose \\\u003C 2.8mmol\u002FL or \\> 23mmol\u002FL);\n* Presence of significant abnormal liver function markers or renal function markers prior to randomization; Note: Severe liver function abnormalities were defined as serum alanine aminotransferase (ALT), or aspartate aminotransferase (AST) \\> 3 times the upper limit of normal (ULN). Significant renal insufficiency is defined as eGFR less than 60 mL\u002Fmin\u002F1.73 m2 (eGFR, calculated using the CKD-EPI formula)\n* Acute ST-elevation myocardial infarction (MI) and\u002For decompensated heart failure (meeting the New York College of Cardiology (NYHA) Heart function grades III and IV) within the past 3 months;\n* Presence of contraindications to intracalvariosseous injection, e.g., skull fracture in the last 3 months, skull infection, subdural\u002Fextradural hematoma, subcutaneous hematoma, skin or subcutaneous infection of the scalp, poorly displayed skull bone marrow niches;\n* Bleeding tendencies considered by the investigators to be detrimental to the procedure include, but are not limited to, platelet counts \\\u003C 100×109\u002FL, and the presence of clotting disorders such as hemophilia;\n* Presence of severe or very severe anemia (hemoglobin \\\u003C60 g\u002FL) at randomization;\n* Patients with severe respiratory diseases (severe chronic obstructive pulmonary disease, respiratory failure, etc.) should be corrected by intubation, tracheotomy, or ventilator;\n* The subjects were considered to have developed clinically significant serious infections, including severe local infections or systemic infections;\n* Diagnosed severe degenerative diseases of the central nervous system such as Alzheimer's Disease (AD), Parkinson's Disease (PD), and severe dementia of all causes, or psychiatric disorders (e.g., schizophrenia, depression, etc.);\n* Subjects with a life expectancy of less than 3 months due to conditions not considered current by the investigators, such as tumors;\n* Known allergy to any component of investigational process therapy drugs and contrast agents;\n* Subjects who are pregnant, breastfeeding or have the possibility of becoming pregnant or plan to become pregnant;\n* Subjects are unable to comply with trial protocols or follow-up requirements;\n* Other circumstances deemed by the investigators to be unsuitable for enrollment (registration of reasons for inability to enroll is required);\n* Have participated in other interventional clinical trials.","18 Years","80 Years",{"count":53,"type":21},6,[55],"NA","A pilot study confirmed the feasibility and safety of neuroprotectant RK-4 intracalvariosseous(ICO) injection in patients with malignant middle cerebral artery infarction (mMCAI), showing a trend in improving 90-day functional scores compared to conventional treatment. The aim of this trial is to investigate the feasibility and safety of neuroprotective agent RK-4 injection using intracalvariosseous injection device in patients with acute large hemispheric infarction (LHI) who has contraindications of reperfusion therapy or have got poor reperfusion therapy outcomes.",[58,59,60],"Stroke","Acute Ischemic Stroke","Blood-Brain Barrier",[62,63,64,65,66,67],"large hemispheric infarction","postsynaptic density protein 95 inhibitor","BBB-bypassing route","brain drug delivery","intracalvariosseous injection","intracalvariosseous injection device",{"date":33,"type":34},{"date":70,"type":21},"2026-04-15",{"date":72,"type":21},"2026-11-15",{"name":40,"class":41},{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":94,"locationsCount":42},"100629567","early-phase-1-expansion-study-of-alt001-in-patients-with-multiple-system-atrophy-100629567","NCT07476352","Expansion Study of ALT001 in Patients With Multiple System Atrophy","ALT001 in MSA","Inclusion Criteria:\n\n* 1\\. Age between 30 and 75 years inclusive, either sex;\n* 2\\. Clinically established or clinically probable MSA (including both MSA-C and MSA-P subtypes);\n* 3\\. Ability to walk independently or with the aid of a walking device for at least 10 meters;\n* 4\\. Provision of written informed consent.\n\nExclusion Criteria:\n\n* 1\\. Evidence of other central nervous system pathologies on brain MRI at screening suggesting a diagnosis of neurodegenerative diseases other than MSA;\n* 2\\. Other significant pathological findings on brain MRI at screening, including but not limited to: cerebral hemorrhage, acute cerebral infarction, aneurysm, vascular malformation, infectious lesions, brain tumors, or other space-occupying lesions (meningiomas or arachnoid cysts with a maximum diameter \\\u003C1 cm do not require exclusion);\n* 3\\. Presence of immune-mediated diseases that are inadequately controlled or require treatment with biologic agents;\n* 4\\. Known history of allergies to biologic agents, such as proteins or cell-based products;\n* 5\\. Receipt of any vaccination within the past 1 month;\n* 6\\. Patients with a prior definitive diagnosis of malignancy or those currently receiving anti-tumor drug therapy;\n* 7\\. Patients with a prior definitive diagnosis of epilepsy or those currently taking anti-epileptic drugs;\n* 8\\. Concurrent severe hepatic insufficiency, renal insufficiency, or severe cardiac insufficiency (severe hepatic insufficiency defined as ALT ≥1.5 times the upper limit of normal or AST ≥1.5 times the upper limit of normal; severe renal insufficiency defined as serum creatinine \\[CRE\\] ≥1.5 times the upper limit of normal or estimated glomerular filtration rate \\[eGFR\\] \\\u003C40 mL\u002Fmin\u002F1.73 m²; severe cardiac insufficiency defined as NYHA class 3-4), or any significant abnormalities on physical examination, vital signs, laboratory tests, or electrocardiogram that, in the investigator's opinion, require further examination or treatment, or may interfere with the study procedures or safety;\n* 9\\. Patients with a history of alcohol or substance abuse, or alcohol or substance dependence within the past 2 years;\n* 10\\. Patients diagnosed with psychiatric disorders according to DSM-V criteria, or those with obvious suicidal intent;\n* 11\\. Patients who are pregnant, lactating, or have the potential to become pregnant, or those planning a pregnancy;\n* 12\\. Inability to comply with follow-up assessments due to other reasons;\n* 13\\. Patients deemed by the investigator to be unsuitable for participation in this study.",{"count":82,"type":21},60,[24],"This is an open-label, single-center, prospective, single-arm clinical study. The primary objective of this study is to evaluate the safety, tolerability, and preliminary efficacy of ALT001 in the treatment of patients with multiple system atrophy (MSA) in a real-world setting.",[86],"Multiple System Atrophy",[29],"2026-03-25",{"date":90,"type":34},"2026-03-30",{"date":92,"type":21},"2026-05-06",{"date":38,"type":21},{"name":40,"class":41},{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":18,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":53},"100631013","intracalvariosseous-plus-intravenous-antibiotics-for-moderate-to-severe-bacterial-meningitis-100631013","NCT07495150","Intracalvariosseous Plus Intravenous Antibiotics for Moderate-to-Severe Bacterial Meningitis","Efficacy and Safety of Intracalvariosseous Combined With Intravenous Injection of Antibiotics in Moderate-to-Severe Bacterial Meningitis","FLAME","Inclusion Criteria:\n\n* 1\\. Age 18-75 years, gender not limited;\n* 2\\. Meeting the diagnostic criteria for moderate to severe bacterial meningitis:\n\n  1. Meeting the diagnostic criteria for bacterial meningitis, i.e., meeting at least item i:\n\n     i. Abnormal body temperature (\\>38℃ or \\\u003C36℃), turbid or purulent Cerebrospinal fluid (CSF) , CSF leukocytosis (\\>500×10⁶\u002FL), CSF glucose\u002Fserum glucose concentration \\\u003C0.4, CSF protein concentration \\>50mg\u002FdL, meeting the clinical diagnosis; ii. In addition to item i, positive microbial tests or cultures of specimen smears, drainage tube heads, implants, and CSF (excluding contamination and colonization), meeting the etiological diagnosis;\n  2. GCS score ≤12 points or a decrease of 2 points from the previous score;\n  3. At least one of the following conditions is present: altered consciousness, seizures, brain parenchymal involvement, severe manifestations such as mechanical ventilation or circulatory support.\n* 3\\. After 48-72 hours of antibiotic treatment, if the investigator determines that the patient's condition shows no significant improvement or continues to worsen, or if at least one of the following conditions is present:\n\n  1. Symptoms and signs related to intracranial infection show no trend of relief or worsen;\n  2. CSF white blood cell count shows no trend of decrease, or increases after decreasing;\n  3. CSF protein concentration shows no trend of decrease, or increases after decreasing;\n  4. CSF\u002Fserum glucose concentration shows no trend of increase, or decreases after increasing;\n  5. CSF bacterial culture remains positive or becomes positive again after initially being negative.\n* 4\\. Based on the patient's condition, treatment with polymyxin B, tigecycline, or vancomycin may be necessary.\n* 5\\. Obtain informed consent.\n\nExclusion Criteria:\n\n* 1\\. History of allergy to polymyxin B, tigecycline, or vancomycin;\n* 2\\. Received intrathecal or intraventricular antibiotic treatment before randomization;\n* 3\\. Patients with severe pulmonary infection\u002Facute respiratory distress syndrome (PaO₂\u002FFiO₂ \\\u003C 150 mmHg, FiO₂ ≥ 0.6, PEEP ≥ 5 cmH₂O) or whose primary cause of mechanical ventilation is not determined to be intracranial infection;\n* 4\\. Patients with a primary extracranial infection focus (e.g., lungs, abdomen, urinary tract, etc.) who, after adequate fluid resuscitation, require vasoactive drugs to maintain MAP ≥ 65 mmHg (e.g., norepinephrine ≥ 0.25 μg\u002Fkg\u002Fmin) and lactate \\> 2 mmol\u002FL, or whose primary cause of critical illness is not determined to be intracranial infection;\n* 5\\. Patients with contraindications to transcranial administration, such as severe skull fracture, poor visualization of the skull diploic, or planned decompressive craniectomy, which may affect transcranial administration.\n* 6\\. Clinical signs of brain herniation, such as unilateral or bilateral pupillary dilation and fixation; or loss of other brainstem reflexes determined by the investigator to be caused by meningitis or brain herniation; or other uncontrollable signs of unstable vital signs;\n* 7\\. Bleeding tendency deemed unfavorable for the procedure by the investigator: abnormal coagulation function (e.g., platelet count \\\u003C50×10⁹\u002FL; prothrombin time \\[PT\\]\\>3s), patients with a previous diagnosis of hemophilia or other coagulation disorders;\n* 8\\. Patients with severe hepatic or renal insufficiency (where severe hepatic insufficiency is defined as alanine aminotransferase (ALT) value ≥3 times the upper limit of normal (ULN) or aspartate aminotransferase (AST) value ≥3 times the ULN; severe renal insufficiency is defined as serum creatinine (CRE) ≥1.5 times the ULN or glomerular filtration rate (eGFR) \\\u003C40 mL\u002Fmin\u002F1.73m²;\n* 9\\. Within the past 3 months, the patient has experienced an acute ST-segment elevation myocardial infarction and\u002For decompensated heart failure (meeting New York Heart Association \\[NYHA\\] functional class III or IV).\n* 10\\. Patients with severe or extremely severe anemia (hemoglobin \\\u003C 60 g\u002FL) at the time of randomization;\n* 11\\. Patients with active hepatitis B infection (positive hepatitis B surface antigen and\u002For positive serum HBV DNA or serum HBV DNA \\> 2 × 10⁸ IU\u002Fml);\n* 12\\. Patients with positive hepatitis C virus antibody or a history of positive testing;\n* 13\\. Patients with positive HIV test or a history of positive testing;\n* 14\\. Pregnant, lactating, or potentially pregnant patients, or patients planning to become pregnant;\n* 15\\. Patients currently participating in other interventional trials or who have used other investigational drugs within one month or five drug half-lives;\n* 16\\. Patients deemed unsuitable for participation in this study by the investigator.",{"count":104,"type":21},86,[55],"Multiple preclinical and clinical studies, including the investigators' published work and the ongoing SOLUTION series, have consistently demonstrated that intracalvariosseous (ICO) injection can markedly increase drug exposure within the central nervous system with acceptable safety. This trial is designed to further evaluate the efficacy and safety of antibiotic delivery via the ICO route in the treatment of bacterial meningitis, particularly in patients with moderate-to-severe disease who have shown an inadequate response to standard therapy.",[60,108],"Bacterial Meningitis",[60,110,111,112,113],"Bacterial meningitis","Prognosis","Intracalvariosseous","Antibiotic","2026-03-21",{"date":116,"type":34},"2026-03-27",{"date":118,"type":21},"2026-04-01",{"date":120,"type":21},"2027-07-01",{"name":40,"class":41},{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":51,"enrollmentInfo":130,"targetDuration":4,"studyType":22,"phases":132,"briefSummary":133,"conditions":134,"keywords":136,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":53},"100544882","the-efficacy-and-safety-of-y-3-intracalvariosseous-injection-versus-intravenous-injection-in-the-treatment-of-acute-large-hemispheric-infarction-100544882","NCT06374667","The Efficacy and Safety of Y-3 Intracalvariosseous Injection Versus Intravenous Injection in the Treatment of Acute Large Hemispheric Infarction","The Efficacy and Safety of Y-3 Intracalvariosseous Injection Bypassing Blood-brain Barrier Versus Intravenous Injection in the Treatment of Acute Large Hemispheric Infarction（SOLUTION-2）","SOLUTION-2","Inclusion Criteria:\n\n* 18≤Age≤80 years;\n* First stroke or complete self-care before the onset of current stroke (mRS 0-1);\n* Administration of drugs can be completed within 24h of the onset of signs and symptoms of neurological deficits (in patients with wake-up strokes or unwitnessed strokes, the time of onset is defined as the time of last normal presentation);\n* Clinical symptoms, signs and imaging diagnosis of cerebral infarction in the area supplied by the middle cerebral artery, together with the following features:\n\n  1. 16≤ NIHSS ≤32 points, and the sum of the scores of motor arm and motor leg is ≥6;\n  2. Imaging suggestive of core infarct area: apparent diffusion coefficient (ADC) values \\\u003C620×10\\^-6mm\\^2\u002Fs lesion volume on magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI) sequences or cerebral blood flow (CBF) \\\u003C30% of volume 70-300 ml on computed tomography perfusion imaging (CTP) or an Alberta Stroke Program Early CT Score (ASPECTS) of 0-6, with inconsistent findings, the investigator is required to make a reasoned judgement by taking into account all the information (scanning time, the imaging method that best responds to the size of infarct, etc.) and record it.\n* NIHSS score not improving or progressing after reperfusion therapy and total score still ≤32.\n* Informed consent signed\n\nExclusion Criteria:\n\n* Complications with other cerebrovascular diseases meet one of the following conditions:\n\n  1. Complicated with acute cerebral hemorrhage and subarachnoid hemorrhage;\n  2. Complicated with acute posterior circulation cerebral infarction or severe posterior circulation stenosis (\\>70%);\n  3. Or imaging suggests that the area of cerebral infarction is involved bilaterally;\n  4. The cause of the TOAST classification was considered as intracranial artery dissection, vasculitis, moyamoya disease and other etiological types.\n* Hemorrhage transformation in the infarction area, hematoma area ≥30% of the infarction area, and has obvious space-occupying effect;\n* Presence of clinical signs of brain herniation formation, e.g., unilateral or bilateral pupil dilation and fixation; cerebral oedema-associated loss of consciousness (NIHSS 1a \\> 2 points), or other loss of brainstem reflexes in the judgement of the investigator, caused by cerebral oedema or cerebral herniation formation; or other signs of instability of vital signs that are difficult to control;\n* Craniotomy decompression was planned before randomization;\n* Refractory hypertension (systolic \\> 200mmHg or diastolic \\> 110mmHg) or hypotension (systolic \\\u003C 70mmHg or diastolic \\\u003C 50mmHg) that is difficult to control with medication;\n* Abnormal blood glucose before randomization (random venous blood glucose \\\u003C 2.8mmol\u002FL or \\> 23mmol\u002FL);\n* Presence of significant abnormal liver function markers or renal function markers prior to randomization;\n* Note: Severe liver function abnormalities were defined as serum alanine aminotransferase (ALT), or aspartate aminotransferase (AST) \\> 3 times the upper limit of normal (ULN). Significant renal insufficiency is defined as eGFR less than 60 mL\u002Fmin\u002F1.73 m² (eGFR, calculated using the CKD-EPI formula)\n* Acute ST-elevation myocardial infarction (MI) and\u002For decompensated heart failure (meeting the New York College of Cardiology (NYHA) Heart function grades III and IV) within the past 3 months;\n* Presence of contraindications to intracalvariosseous injection, e.g., skull fracture in the last 3 months, skull infection, subdural\u002Fextradural hematoma, subcutaneous hematoma, skin or subcutaneous infection of the scalp, poorly displayed skull bone marrow niches；\n* Bleeding tendencies considered by the investigators to be detrimental to the procedure include, but are not limited to, platelet counts \\\u003C 100×10\\^9\u002FL, and the presence of clotting disorders such as hemophilia；\n* Presence of severe or very severe anemia (hemoglobin \\\u003C60 g\u002FL) at randomization；\n* Patients with severe respiratory diseases (severe chronic obstructive pulmonary disease, respiratory failure, etc.) should be corrected by intubation, tracheotomy, or ventilator;\n* The subjects were considered to have developed clinically significant serious infections, including severe local infections or systemic infections;\n* Diagnosed severe degenerative diseases of the central nervous system such as Alzheimer's Disease (AD), Parkinson's Disease (PD), and severe dementia of all causes, or psychiatric disorders (e.g., schizophrenia, depression, etc.);\n* Subjects with a life expectancy of less than 3 months due to conditions not considered current by the investigators, such as tumors;\n* Known allergy to any component of investigational process therapy drugs and contrast agents;\n* Subjects who are pregnant, breastfeeding or have the possibility of becoming pregnant or plan to become pregnant;\n* Subjects are unable to comply with trial protocols or follow-up requirements;\n* Other circumstances deemed by the investigators to be unsuitable for enrollment (registration of reasons for inability to enroll is required);\n* Have participated in other interventional clinical trials.",{"count":131,"type":21},134,[55],"A pilot study confirmed the feasibility and safety of neuroprotectant Y-3 intracalvariosseous(ICO) injection in patients with malignant middle cerebral artery infarction (mMCAI), showing a trend in improving 90-day functional scores compared to conventional treatment. The aim of this trial is to further investigate the efficacy and safety of ICO injection of Y-3 compared to intravenous injection in patients with acute large hemispheric infarction(LHI) who has contraindications of reperfusion therapy or have got poor reperfusion therapy outcomes.",[135,60],"Stroke, Acute Ischemic",[62,137,63,64,65,66],"Y-3","RECRUITING","2025-01-24",{"date":141,"type":34},"2025-01-28",{"date":143,"type":34},"2024-04-22",{"date":145,"type":21},"2027-03-15",{"name":40,"class":41},""]