E-Selectin Nasal Instillation to Prevent Secondary Stroke


Phase 1 Results N/A

Eligibility Criteria

1. Occurrence of any type or location of stroke (acute ischemic or primary hemorrhagic stroke) at least 31 days, but not more than 120 days prior to enrollment confirmed by brain imaging (CT or MRI).
2. Age equal to or greater than 45 years.
3. Modified Rankin Score of 0-2 (functionally independent) at the time of study enrollment and determined to be clinically and neurologically stable by the enrolling investigator.
Patients with any of the following conditions will not be eligible for participation in this study:
1. Intracranial or extracranial dissection, Moyamoya disease, vasculitis, radiation-induced vasculopathy, fibromuscular dysplasia, venous thrombosis.
2. Current treatment with Immunosuppressive medication including: prednisone, cyclophosphamide, cyclosporine, methotrexate, azathioprine, mycophenolate mofetil, anti-CD3 moab (Othoclone OKT3), takrolimus (FK506), sirolimus, anti-IL2r moab (simulect, zenapax), etanercept, infliximab, lenercept, thymoglobulin; thalidomide.
3. Known active autoimmune diseases (RA, LE, MS, Myasthenia Gravis, etc.).
4. Active cancer or lymphoproliferative diseases. (except for basal cell carcinoma)
5. Thrombocytopenia (platelets less than 100,000).
6. HIV or other known immunodeficiencies.
7. Recent major surgery performed within one month of study enrollment.
8. Active systemic infections, or severe focal or upper respiratory infections (URI).
9. Alcohol or substance abuse.
10. Dementia or psychiatric problems (determined by examination, mini-mental status test) that prevents the patient from providing informed consent or following an outpatient program reliably.
11. Pregnancy (urine pregnancy test will be given to women of childbearing potential).
12. Severe rhinopathy or sinusitis.
13. Continuing use of any other over the counter, prescribed or recreational intranasal drug.
14. History of NCI grade 3 epistaxis within 1 month.
15. Exposure to an investigational drug within the 30 days prior to screening for this study.
16. Planned surgery (e.g. carotid or cardiac surgery) or endovascular intervention during the study period until study variables have returned to baseline to prevent attributions of surgical complications to E-selectin tolerization.
17. Patients who are not eligible for or unable to tolerate a brain MRI prior to the start of study drug.