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Plan to have a neurovascular procedure (e.g., carotid endarterectomy, stent placement, etc.) within the first year following stroke ĩ.
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#Athersys anti stroke drug 36 hours Activator#
Initiation of intravenous (IV) tissue plasminogen activator (tPA) infusion >4.5 hours and/or mechanical reperfusion (MR) (defined as time of groin puncture) >8 hours after the onset of stroke Ĩ.
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Less than 6 hours between the Screening and Baseline NIHSS assessment ħ. Note: Onset of stroke >28 hours prior to the start of Screening would not allow for administration of investigational product per protocol Ħ. Effective methods of contraception are defined as those that result in a low failure rate (28 hours prior to the start of Screening Agree to use a medically accepted, effective method of avoiding pregnancy through the Day 90 Visit. Not of childbearing potential, defined as one who has been postmenopausal for at least 1 year, or has been surgically sterilized orī. Female subjects must not be pregnant, breastfeeding, or planning on becoming pregnant during the study and either:Ī. A modified Rankin Scale (mRS) score of 0 or 1 prior to the onset of symptoms of the current stroke, by either self-reported history or by family/caregiver report ħ. Confirmation of hemispheric cortical infarct by brain magnetic resonance imaging (MRI) or computed tomography (CT) demonstrating an acute ischemic infarct measuring 5 mL and 100 mL Ħ.
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Note: The Screening NIHSS score used for determination of eligibility should be collected as soon as possible following admission to the hospital, or in the event a subject receives concomitant reperfusion therapy, the subject’s Screening NIHSS score must be collected within 4 hours following completion of the last reperfusion (mechanical or pharmacologic) therapy ĥ. Occurrence of a moderate to moderately severe stroke with a persistent neurologic deficit documented by a National Institutes of Health Stroke Scale (NIHSS) score of 8 to 20 (inclusive) that does not change by 4 points from the Screening to the Baseline assessment For a stroke that occurred during sleep, or in an individual unable to report the time that symptoms began, the time of onset is defined as the time point when the subject was last observed to exhibit normal neurological function or was self-reported to have normal function Ĥ. Note: Time of onset is defined as the time point, if known, when symptoms first began. Onset of stroke symptoms must have occurred 18 to 36 hours prior to the planned start of administration of the investigational product Clinical diagnosis is defined as rapidly developed clinical signs of 1 or more focal (and potentially accompanying global) persistent disturbance(s) of cerebral function, with no apparent cause other than arterial occlusive ischemic stroke that involves cerebral cortex ģ. O This inclusion criterion requires clinical signs that are consistent with imaging abnormalities required under inclusion criterion #5. Clinical diagnosis of ischemic stroke involving cerebral cortex Male or female subjects 18 years of age or older Ģ. Subjects will be eligible for the study if they meet all of the following inclusion criteria:ġ. To evaluate the mechanism of action of MultiStem through blood biomarkers, and spleen and brain imaging outcomes in subjects with ischemic stroke. To evaluate the impact of MultiStem on quality of life and healthcare and rehabilitation services utilization in subjects with ischemic stroke and The tertiary objectives of this study are the following: To evaluate the safety of MultiStem in subjects with ischemic stroke. To evaluate the efficacy of MultiStem on functional, neurological, mortality, secondary infection, and hospitalization outcomes in subjects with ischemic stroke and The secondary objectives of this study are the following: The primary objective of this study is to evaluate the efficacy of MultiStem on functional outcome in subjects with ischemic stroke.