Aleeto in Acute ISchemic Stroke：A RandomISed Controlled Clinical Trial

Prior treatment

• 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.

Other illness

• 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.

Lab values

• 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).

Age

• Severe organic diseases with expected survival time \<5 years, such as malignant tumor.

Other

• 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.

• 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.