Aleeto in Acute ISchemic Stroke：A RandomISed Controlled Clinical Trial

Ki vehet részt

• Age between 30 and 80 years (30 ≤ age ≤ 80)
• Diagnosis of acute ischemic stroke confirmed by CT or MRI, according to the "Key Points for Diagnosis of Major Cerebrovascular Diseases in China 2019."
• Time from symptom onset ≤ 72 hours
• NIHSS score between 6 and 24, with a score of ≥ 1 on items 5 and 6 of the NIHSS
• Pre-stroke mRS (modified Rankin Scale) < 2, indicating independent activities of daily living
• Signed informed consent

Ki nem vehet részt

• Combined with alcohol and drug abuse history
• Received any vaccinations within the past 28 days
• Use of other investigational drugs within 30 days or 5 drug half-lives
• Intracranial hemorrhagic diseases identified by head CT: cerebral hemorrhage, extradural hemorrhage, subarachnoid hemorrhage, intraventricular hemorrhage, etc
• Combined with other active and major neurological diseases (such as induced seizures, poor drug control of recurrent seizures, multiple sclerosis, intracranial tumors, etc.)
• Resistant Hypertension, systolic pressure ≥220mmHg or diastolic pressure ≥120mmHg
• Known history of allergy to biological agents such as proteins and cell products
• History of intracranial or spinal surgery, major surgery, or severe physical trauma within the past 4 weeks
• History of infectious diseases (HIV positive or positive test history, HCV antibody positive or positive test history, HBV surface antigen positive and/or serum HBV DNA positive or serum HBV DNA > 2 × 10\^8 IU/ml)
• Severe renal or hepatic insufficiency. (Severe hepatic insufficiency is defined as alanine aminotransferase (ALT) value>3 times normal upper limit or Aspartate aminotransferase (AST)>3 times normal upper limit; Severe renal insufficiency is defined as creatinine>1.5 times normal upper limit or creatinine clearance < 50 ml/min, or over stage 3 of chronic kidney disease), severe heart failure (New York Heart Association grades III - IV)
• History of Hemostatic disorder, systemic bleeding, thrombocytopenia or neutropenia, drug-induced hematology or liver dysfunction, white blood cell count <2×10\^9/L or platelet count <100×10\^9/L
• History of severe anemia within the past 1 month (hemoglobin < 90g/L)
• Severe organic diseases with expected survival time <5 years, such as malignant tumor
• Body Mass Index (BMI) < 16kg/m2 or BMI> 35kg/m2
• Women of child bearing potential, pregnant or breastfeeding
• Individual who have difficulty communicating verbally to the extent that they are unable to communicate, understand or follow instructions normally, and are unable to cooperate with treatment and evaluation
• Unable to complete follow-up due to geographical or other reasons
• The researchers believe that the patient is not suitable to participate in this study
• Participated in other clinical trials