MultiStem is regenerative medicine derived from donated human cells to treat acute ischemic stroke within 36 hours after symptom onset. Stroke leads to brain cell injury and many stroke patients suffer functional deficits as results. The purpose of this study is to evaluate safety and effectiveness of MultiStem on functional outcome in subjects with ischemic stroke.
Investigator-initiated, phase 3 multicenter, prospective randomized open-, blinded-endpoint (PROBE) controlled trial to test whether treatment of obstructive sleep apnea (OSA) with continuous positive airway pressure is effective for secondary prevention and recovery after stroke.
Patients with recent (≤14 days) acute ischemic stroke or high-risk TIA (ABCD2 ≥4) are enrolled during their acute or rehabilitation hospitalization and treated for 6 months. After consent, a portable cardiopulmonary sleep apnea test (the Nox T3) is used to screen for OSA (AHIT3≥10) and to exclude central sleep apnea (where CAI ≥50% of the total AHIT3). aCPAP is then used on one night to determine tolerability (the "run-in" night). Subjects who use the device for ≥4 hours on that night, and do not have excessive treatment-emergent central sleep apnea (CAI remains <10 on aCPAP machine-generated data), are randomized to receive either 6 months of aCPAP plus usual medical therapy, or usual medical therapy alone. Adherence information is provided to subjects in the intervention group, to offer education about treatment and to increase treatment adherence. Subjects and their caregivers also are taught about aCPAP use. Through a centralized service, managed by FusionHealth, adherence to aCPAP is monitored in nearly real time in most cases by wireless means, and supported remotely throughout the treatment period.
Factor XI is a protein involved in the blood clotting cascade. Blood clots frequently block brain blood vessels causing ischemic strokes. Bleeding in the brain is a major concern for clinicians when treating patients with stroke or risk for stroke. Over the last decade, a new type of drug called a selective oral direct thrombin and Factor Xa inhibitors (DOACs) has been introduced that reduces the likelihood of bleeding when treating and preventing strokes. The purpose of this study is to test the safety and effectiveness of a new stroke medication that block Factor XI and compare it to aspirin alone, especially regarding prevention of stroke without increasing the risk of brain bleeding.
This study is gathering patient information and a saliva sample from people who have had a type of stroke called an intracerebral hemorrhage (ICH). Risk factors will be identified and analyzed for their contribution to the ICH as well as their effect on long term patient outcomes. Patients will be contacted over phone at 3 and 12 months after enrollment and asked a series of short questions about how they are feeling, how hard or easy it is to perform daily tasks, and any change in medication.