Inclusion Criteria:

1. Males or females 18 to 85 years of age, inclusive

2. Have suffered an acute hemispheric ischemic stroke, defined as acute, focal, neurological deficit(s), secondary to a presumed vascular event, which must include both or one of the following:

   • At least one of the following components (as reflected by at least 1 point on any of the corresponding items of the NIHSS: 9, 3 or 11):

     • Language dysfunction (aphasic disorder, excluding dysarthria)
     • Visual field defect (excluding monocular blindness)
     • Extinction and Inattention (formerly Neglect),
   • An indication on routine diffusion-weighted magnetic resonance imaging (DW-MRI) or computed tomography perfusion scan at screening /baseline that the acute stroke involves the cerebral cortex
3. Have suffered the onset of an acute ischemic stroke that can be evaluated and treatment initiated within 1 to 9 hours after the onset of acute ischemic stroke symptoms (onset is defined as the time that the subject was last seen in a normal state, or bedtime for unwitnessed strokes occurring during sleep)
4. Have at screening a NIHSS score of 10 to 16, inclusive
5. Have readily accessible peripheral venous access for clinical trial material (CTM) administration and blood sampling
6. Have the ability to understand the requirements of the study and be willing to provide written informed consent (IC) (as evidenced by signature on an informed consent document approved by an institutional review board (IRB) or independent ethics committee (IEC), and agree to abide by the study restrictions and return for the required assessments (In the event of incapacitated subjects, informed consent will be sought from a legally acceptable representative or by any other means as approved by the IRB or IEC).
7. Have provided written authorization for use and disclosure of protected health information (PHI) in accordance with the Health Insurance Portability and Accountability Act (HIPAA) in the United States and the Personal Information Protection and Electronic Documents Act (PIPEDA) in Canada

Exclusion Criteria:

1. Have an intracerebral or subarachnoid hemorrhage per screening/baseline computerized tomography (CT) scan or susceptibility-weighted magnetic resonance imaging (MRI)
2. Be a candidate for thrombolytic therapy or have been treated with thrombolytic therapy for the current stroke
3. Be delirious, comatose or stuporous (a score of ≥2 on item 1.a of the NIHSS) or demented, or having a mental impairment that in the investigator's opinion renders the subject incapable to participate in the study
4. Have neurological or non-neurological comorbidities that in the investigator's opinion may lead, independent of the current stroke, to further deterioration in the subject's neurological status during the trial period, or may render the study's neurological assessments inconclusive for the purpose of evaluating solely the stroke's effects (e.g., metabolic encephalopathies, hemiplegic migraine, multiple sclerosis, central nervous system tumor, convulsive disorder, monocular blindness)
5. Have rapid spontaneous improvement of neurological signs during screening/baseline assessments
6. Have premorbid neurological deficits and functional limitations assessed by a retrospective (pre-current stroke) Modified Rankin Scale score of >1
7. Have suffered a stroke within 90 days of the screening/baseline assessments that is either diagnostically confirmed or assumed to be in the same cerebral territory as is the current acute stroke
8. Be a female of childbearing potential (less than 2 years' postmenopausal or not surgically sterilized) who is not willing to use adequate and effective birth control measures for the duration of the trial. Effective birth control measures include hormonal contraception, a barrier method such as a diaphragm, intrauterine device (IUD) and/or condom with spermicide (IUD, diaphragm, condoms alone or the rhythm method are not considered reliable methods)
9. Have a positive urine pregnancy test at screening/baseline or be a lactating female