IVIG in Acute Ischemic Stroke: A Pilot Study "IVIG/AIS"


Phase 1 Results N/A

Eligibility Criteria

Inclusion Criteria

1. Onset of neurological symptoms between 4.5 and 8 hours
2. Male or Female age 45 -75 years old
3. Score of 10-15 points on the National Institutes of Health Stroke Scale (NIHSS) with clinical signs suggestive of ischemic stroke
4. Acute brain ischemia with a distinct penumbra (at least 20%), measured by magnetic resonance perfusion imaging (PI) and diffusion-weighted imaging (DWI), in the territory of the middle cerebral artery, anterior cerebral artery, or posterior cerebral artery with a hemispheric distribution
5. Ability and willingness to provide informed consent and comply with study requirements and procedures

Exclusion Criteria

1. Eligibility for acute thrombolytic (rtPA) treatment
2. Normal brain MRI
3. Transient ischemic attack or rapidly improving neurological symptoms
4. Previous disability
5. Hemorrhagic stroke on brain MRI (T2*/SWI)
6. Ongoing infection defined by clinical and laboratory signs: an evidence-based guideline will be followed to detect infectious complications (in short, physical and laboratory measures including WBC, ESR, hsCRP, PCT, fever, abnormal urine, chest X-ray or positive cultures)
7. Diagnosis of malignancy
8. Known sensitivity to any ingredients in the study drug or radiological contrast material
9. Participation in another clinical trial within the past 30 days
10. Stroke in the previous 3 months
11. Chronic liver, kidney or hematological disease
12. Contraindications to MRI -Brain aneurysm clip, implanted neural stimulator, implanted cardiac pacemaker or defibrillator, cochlear implant, ocular foreign body e.g. metal shavings, other implanted medical devices: (e.g. Swan Ganz catheter) insulin pump, metal shrapnel or bullet.
13. Diabetes
14. Hypertension
15. Females who are pregnant or breastfeeding