Actively Recruiting
Aleeto in Acute ISchemic Stroke：A RandomISed Controlled Clinical Trial
Led by Beijing Tiantan Hospital · Updated on 2025-09-03
192
Participants Needed
1
Research Sites
45 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Aleeto in Acute ISchemic Stroke：A RandomISed Controlled Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 30 and 80 years
- Diagnosis of acute ischemic stroke confirmed by CT or MRI
- Stroke symptom onset within 72 hours
- NIH Stroke Scale score between 6 and 24, with at least 1 point on items 5 and 6
- Pre-stroke modified Rankin Scale score less than 2 (independent daily living)
- Signed informed consent
You will not qualify if you...
- Presence of intracranial hemorrhagic diseases (e.g., cerebral hemorrhage, extradural hemorrhage, subarachnoid hemorrhage, intraventricular hemorrhage)
- Other active major neurological diseases (e.g., seizures uncontrolled by medication, multiple sclerosis, intracranial tumors)
- History or positive tests for infectious diseases such as HIV, hepatitis C, or hepatitis B with high viral load
- Severe kidney or liver failure, severe heart failure (NYHA class III-IV)
- Resistant hypertension with systolic pressure 220 mmHg or diastolic pressure 120 mmHg
- History of bleeding disorders, low blood cell counts, or drug-induced blood or liver dysfunction
- Severe anemia within the past month (hemoglobin < 90 g/L)
- Body mass index less than 16 or greater than 35 kg/m2
- Severe life-threatening diseases with expected survival under 5 years (e.g., cancer)
- Women who are pregnant, breastfeeding, or of childbearing potential
- Severe communication difficulties preventing cooperation
- History of alcohol or drug abuse
- Known allergy to biological agents like proteins or cell products
- Recent major surgery or severe trauma within 4 weeks
- Vaccination within the past 28 days
- Use of other experimental drugs within 30 days or 5 half-lives
- Unable to complete follow-up due to location or other reasons
- Investigator judgment deeming participant unsuitable
- Participation in other clinical trials
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital
Beijing, China
Actively Recruiting
Research Team
Y
YiLong Wang
CONTACT
W
WeiQi Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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