G-CSF employing neuroprotection study for ischemic stroke -Phase 2 clinical trial-(GENESIS-2)
Phase 2
- Conditions
- acute cerebral infarction
- Registration Number
- JPRN-UMIN000006607
- Lead Sponsor
- Tokai University, School of Medicine, Division of Neurology, Department of Internal Medicine.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
1.Splenomegaly or splenic lesions on echo. 2.Leukocytosis more than 15000/mm3 3.Past history of G-CSF treatment. 4.Plan for percutaneous angiography or bypass operations. 5.Difficult to perform MRI. 6.Past histries of symptomatic intracranial hemorrhage, bleeding tendency or coagulating disorders. 7.Hyper reactivity to G-CSF. 8.Congestive heart failure or uncontrollable angina. 9.Thrombocytopenia(less than 140000/mm3) 10.Liver dysfunction(AST(GOT),ALT(GPT) more than 100 IU/L) 11.Renal dysfunction (creatinine 1.5mg/dl and more) 12.Difficult to continue this trial due to social problems, etc. 13.Join other clinical trials. 14.Inappropriate to enroll in this trial by the judgment of the doctor.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety(leukocyte count, size of spleen) Clinical outcome at 3 months after the onset(mRS, BI)
- Secondary Outcome Measures
Name Time Method Size of infarct on MRI, biomarkers such as inflammation cytokines, etc.