G-CSF employing neuroprotection study for ischemic stroke -Phase 2 clinical trial-(GENESIS-2)

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2011
INTERVENTION: G‐CSF(75 micrograms/body) is intravenously given twice a day for 5 days at 24 hours after onset. G‐CSF(150 micrograms/body) is intravenously given twice a day for 5 days at 24 hours after onset. Saline (50ml) as a placebo is intravenously given twice a day for 5 days at 24 hours after onset. CONDITION: acute cerebral infarction PRIMARY OUTCOME: Safety(leukocyte count, size of spleen) ; Clinical outcome at 3 months after the onset(mRS, BI) SECONDARY OUTCOME: Size of infarct on MRI, biomarkers such as inflammation cytokines, etc. INCLUSION CRITERIA: 1.Acute ischemic stroke at 24 hours after onset. 2.Patients with occlusion of middle cerebral artery territory, at least including its cortical branch, on MRI. 3.Atherothrombotic or cardioembolic strokes. 4.NIHSS:4‐22 points 5.Age:45‐85 years old. 6.Obtain informed consent by the document.
Epistemonikos ID: 66adf5bb57a2f985c35dc82352d4aa1f1f8dae18
First added on: Aug 22, 2024