Efficacy and Safety Study of GM602 in Patients With Acute Middle Cerebral Artery Ischemic Stroke Within 18 Hours

Inclusion Criteria: * \> 18 years old * Be eligible for MRI or CT scan * Have suffered acute ischemic stroke in the middle cerebral artery (MCA) distribution, as verified by the Screening diffusion-weighted imaging (DWI) abnormality and Screening perfusion-weighted imaging pressure-work index (PWI ) abnormality * Have NIH Stroke Scale (NIHSS) score total score of 9-20 inclusive at screening * Have suffered acute ischemic stroke within 18 hours * Have been functionally independent with a Modified Rankin Score (mRS) of 0 or 1 prior to suffering stroke * Patients who received tPA or FDA approved mechanical device can also enroll * completed informed consent form Exclusion Criteria: * Have history of stroke in the past 3 months * Cannot be evaluated using MRI/CT * Have stroke of the brainstem or cerebellum * Have clinical presentation consistent with acute MI by EKG criteria (STEMI) at screening * Have hemorrhage revealed by CT or MRI scan * Have \> 1/3 MCA territory HYPER intensity as seen on MRI OR \>1/3 MCA territory HYPO intensity as seen on CT * Have blood sugar level \>400 mg/DL or\<50 mg/dL * Have kidney disease, creatinine \> 2.0 * Have had recent (within 90 days) serious head trauma or head trauma with loss of consciousness * Have any prior history of seizure * Have clinically relevant pre-existing neurological deficit (Historical Rankin score ≥ 2) * Have any other known clinically significant medical disorder (cardiovascular, hepatic, renal, endocrine, respiratory, immunological, cancer, AIDS) * Life expectancy of less than 6 months due to comorbid conditions * Women of child bearing potential who are pregnant or breast-feeding or unable to practice birth control during the study period * Have participated in any other trial of an investigational agent within 90 days prior to screening * Informed consent cannot be obtained * Unable to participate in study visits