Aleeto in Acute ISchemic Stroke：A RandomISed Controlled Clinical Trial

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Acute Ischemic Stroke

In brief

This study is a prospective, double-blind, 1:1:1 randomized controlled study aimed at evaluating the efficacy and safety of Aleeto treatment compared to placebo in improving the NIHSS score at 14 days in patients with moderate to severe acute ischemic stroke. It also aims to explore the neuroprotective effects of Aleeto in moderate to severe acute ischemic stroke and provide data support and evidence for future clinical trials and evidence-based medicine.

Key facts

Study ID

NCT06759753

Run by

Beijing Tiantan Hospital

People needed

192

Starts

2025-03-21

Expected to finish

2026-01-31

Last updated by the study team

2025-09-03

Who can join

Age: 30 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.).
• 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).
• Resistant Hypertension, systolic pressure ≥220mmHg or diastolic pressure ≥120mmHg.
• 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).
• Body Mass Index (BMI) < 16kg/m2 or BMI> 35kg/m2.
• Severe organic diseases with expected survival time <5 years, such as malignant tumor.
• 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.
• Combined with alcohol and drug abuse history.
• 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.
• Received any vaccinations within the past 28 days.
• Use of other investigational drugs within 30 days or 5 drug half-lives.
• 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.

Where it is running

• Beijing Tiantan Hospital — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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