ABSTRACT
BACKGROUND: There is growing interest in neurorestorative and reparative therapies after acute stroke. MultiStem is an allogeneic cell therapy treatment comprising a population of multipotent adherent bone marrow cells that has shown safety in clinical trials of myocardial infarction and graft vs. host disease, as well as preclinical evidence of activity in stroke and other neurological damage models. MultiStem is now being evaluated in a clinical trial in patients that have suffered an ischemic stroke, in which the product is administered intravenously 24-36 h after the ischemic event. METHODS: The Phase 2 randomized, double-blind, placebo-controlled, multicenter dose-escalation trial will consist of three treatment cohorts, including a placebo group, and two treatment groups involving dose tiers of either 400 million or 1200 million cells per patient. Patients will be treated at 24-36 h after stroke. The two primary objectives are to determine the highest well-tolerated and safe single dose of MultiStem up to a maximum of 1200 million total cells in subjects with ischemic stroke and to determine the efficacy of MultiStem on functional outcome in subjects with stroke as measured by the modified Rankin Scale at 90 days. Patients will also be evaluated using the National Institutes of Health Stroke Scale and Barthel Index. The study will explore other aspects including, uniquely, the measurement of spleen size after stroke by magnetic resonance imaging or computed tomography imaging. CONCLUSIONS AND FUTURE DIRECTION: If MultiStem is safe and there is a signal of efficacy, a late stage phase IIb-III trial is planned.
Subject(s)
Cell- and Tissue-Based Therapy/methods , Mesenchymal Stem Cell Transplantation/methods , Outcome Assessment, Health Care , Stroke/therapy , Adolescent , Adult , Aged , Brain Ischemia/complications , Double-Blind Method , Female , Humans , Male , Mesenchymal Stem Cells/physiology , Middle Aged , Stroke/etiology , Transplantation, Homologous , Young AdultABSTRACT
BACKGROUND AND PURPOSE: Basilar artery occlusion remains one of the most devastating subtypes of stroke. Intravenous and intra-arterial therapy have altered the natural history of this disease; however, clinical results remain poor. Therefore, exploring more aggressive and innovative management is warranted. METHODS: Six consecutive patients presenting with a basilar artery occlusion were treated with the same general algorithm of intra-arterial tissue plasminogen activator and mechanical thrombectomy with the Merci retrieval system. If complete recanalization was not achieved after two passes, manual syringe aspiration through a 4.3F catheter was employed. RESULTS: All interventions utilizing aspiration thrombectomy resulted in recanalization, with five out of six cases displaying TIMI3/TICI3 flow and one patient resulting in complete recanalization of the basilar artery with persistent thrombus in one P2 segment (TIMI2/TICI2B). All patients survived, with five out of six independent in activities of daily living at 3 months (mRS 0-2). CONCLUSIONS: Our small case series indicates that aspiration thrombectomy performed manually through a 4.3F catheter can facilitate recanalization of basilar artery occlusion with acceptable clinical outcomes.
