Aleeto for moderate to severe acute ischemic stroke

Aleeto in Acute ISchemic Stroke：A RandomISed Controlled Clinical Trial

This trial will test whether Aleeto, given within 72 hours of symptom onset, helps improve neurological recovery in adults with moderate to severe acute ischemic stroke compared with placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 192 (estimated)
• Ages: 30 Years to 80 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT06759753 on ClinicalTrials.gov

What this trial studies

This is a prospective, double-blind, randomized (1:1:1) phase 2 study comparing Aleeto to placebo in patients with moderate to severe acute ischemic stroke. Eligible adults (age 30–80) with CT- or MRI-confirmed ischemic stroke within 72 hours and NIHSS 6–24 are assigned to receive Aleeto (one of the dosing arms) or placebo under blinded conditions. The primary endpoint is change in NIHSS score at 14 days, with secondary assessments of safety, functional outcomes, and exploratory neuroprotective biomarkers. Results are intended to inform safety and efficacy signals for future larger trials.

Who should consider this trial

Good fit: Adults aged 30–80 with CT/MRI-confirmed acute ischemic stroke within 72 hours, NIHSS 6–24, pre-stroke mRS <2, and who can provide informed consent are the intended participants.

Not a fit: Patients with intracranial hemorrhage, major active neurological diseases, certain infectious disease histories, those outside the 72-hour window, or with strokes outside the specified NIHSS range are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, Aleeto could improve early neurological recovery and reduce disability after acute ischemic stroke.

How similar studies have performed: Exosome-derived and cell-based neuroprotective therapies have shown promise in preclinical studies and early-phase trials, but clinical evidence of efficacy in acute ischemic stroke remains limited.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Intracranial hemorrhagic diseases identified by head CT: cerebral hemorrhage, extradural hemorrhage, subarachnoid hemorrhage, intraventricular hemorrhage, etc.
2. Combined with other active and major neurological diseases (such as induced seizures, poor drug control of recurrent seizures, multiple sclerosis, intracranial tumors, etc.).
3. 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).
4. 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).
5. Resistant Hypertension, systolic pressure ≥220mmHg or diastolic pressure ≥120mmHg.
6. 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.
7. History of severe anemia within the past 1 month (hemoglobin \< 90g/L).
8. Body Mass Index (BMI) \< 16kg/m2 or BMI\> 35kg/m2.
9. Severe organic diseases with expected survival time \<5 years, such as malignant tumor.
10. Women of child bearing potential, pregnant or breastfeeding.
11. 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.
12. Combined with alcohol and drug abuse history.
13. Known history of allergy to biological agents such as proteins and cell products.
14. History of intracranial or spinal surgery, major surgery, or severe physical trauma within the past 4 weeks.
15. Received any vaccinations within the past 28 days.
16. Use of other investigational drugs within 30 days or 5 drug half-lives.
17. Unable to complete follow-up due to geographical or other reasons.
18. The researchers believe that the patient is not suitable to participate in this study.
19. Participated in other clinical trials.

Where this trial is running

Beijing

• Beijing Tiantan Hospital — Beijing, China (Recruiting)

Study contacts

• Principal investigator: YiLong Wang — Beijing Tiantan Hospital
• Study coordinator: YiLong Wang

Conditions Acute Ischemic Stroke; Aleeto; Placebo parallel-controlled; Double Blind Study; Randomized Controlled Trial