2 Clinical Trials for Various Conditions
The purpose of this study is to demonstrate the safety of the delivery of ALD-401 by intracarotid infusion and to assess efficacy of treatment in subjects who have had unilateral, predominately cortical, ischemic strokes in the middle cerebral artery (MCA). ALD-401 is made from the stroke patient's bone marrow and infused 13-19 days after the stroke.
This is a retrospective chart review of patients that were admitted with large MCA stroke to the Fairview system hospitals between December 2017-December 2018. Patients ischemic stroke volumes will be measured by taking the area of the infarction and multiplying it by the thickness of each CT or MRI slice, the summation of these volumes is the final volume of the ischemic lesion in cubic centimeters. Patients with stroke volumes greater than 70 cc will be included in the study. Patient midline shift will be measured in millimeters at the level of foramen of Monroe anytime during their initial admission and all patients with a shift greater than 1mm will be included. The midline shift will be documented on the first follow-up brain scan (CT or MRI) at least six hours after the initiation of osmotic therapy. Data will be collected from patient charts including: Age, sex, NIHSS on presentation and discharge, history of diabetes mellitus, hypertension, coronary artery disease, atrial fibrillation, and chronic kidney disease. The type of osmotherapy, along with change in serum sodium or osmolality and dose, will also be documented. In patients that did not receive osmotherapy, midline shift will be documented on the first 24-hour scan and every subsequent scan in 24-hour intervals. Death during a hospital stay will also be recorded. The investigators will use the SAS statistical suite to analyze this data.