Neuron Therapeutics, Inc. (Nfl) is developing a perfluorocarbon-containing artificial cerebrospinal fluid (Revoxyn) that can deliver oxygen and other nutrients directly to brain tissue even when vessels are occluded and cerebral blood flow compromised by ischemic stroke, a "brain attack." Preclinical studies demonstrated that ventricular perfusion with Revoxyn reduces infarct volume by >90 percent and reverses loss of EEG activity. In Phase I of this FAST TRACK SBIR application NTI will: 1) determine whether single pass perfusion with Revoxyn delivered via the ventricle-to-lumbar spine route is safe for patients with severe hemispheric ischemic stroke; 2) determine to what extent the composition of Revoxyn changes during cerebral perfusion in man; and 3) design, fabricate, and test on the lab bench a prototype recirculating perfusion device suitable for preclinical safety testing in vivo. Feasibility will be demonstrated if 1) the Revoxyn single pass perfusion system is safe in man; 2) '75 percent of input perfluorocarbon is recovered in the lumbar fluid; 3) the recirculating RDS-alpha prototype can a) reliably maintain pH, C02 and 02 tensions of conditioned Revoxyn within specifications for 24 h; b) run unattended without shutdown for 24 h; c) successfully prevent delivery of Revoxyn at pressures >25 torr under conditions of outflow restriction. PROPOSED COMMERCIAL APPLICATION: Not Available
Public Health Relevance Statement: Project Terms: patient oriented research; stroke therapy; human therapy evaluation; respiratory oxygenation; oxygen transport; emulsions; cerebrospinal fluid; human subject; fluosol; brain circulation; stroke; cerebral ischemia /hypoxia; cerebral cortex
