DIRECT CEREBRAL OXYGENATION FOR ISCHEMIC STROKE

直接脑氧合治疗缺血性中风

• 批准号: 6311388
• 负责人: Timothy J Pelura
• 金额: $ 32.01万
• 依托单位: NEURON THERAPEUTICS, INC.
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-30 至 2002-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6311388
• 关键词: brain circulation; cerebral cortex; cerebral ischemia /hypoxia; cerebrospinal fluid; emulsions; fluosol; human subject; human therapy evaluation; oxygen transport; patient oriented research; respiratory oxygenation; stroke; stroke therapy

DESCRIPTION(adapted from applicant's abstract): 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

描述（改编自申请人摘要）：Neuron Therapeutics，Inc.（NFL） 正在开发一种含有全氟化碳的人工脑脊液 （Revoxyn）可以将氧气和其他营养物质直接输送到脑组织 即使当血管被阻塞并且脑血流受到缺血性损害时， 中风，一种“脑攻击”。“临床前研究表明， 用Revoxyn灌注可使梗死体积减少> 90%，并逆转损失 EEG活动。 在此FAST TRACK SBIR应用的第一阶段，NTI将：1）确定是否 通过脑室至腰椎输送Revoxyn的单通道灌注 严重半球缺血性卒中患者安全; 2） 确定在大脑活动期间Revoxyn的组成变化的程度 3）设计、制造和在实验室工作台上测试 适用于临床前安全性的原型再循环灌注装置 体内测试将证明可行性，如果1）Revoxyn单次通过 灌注系统对人体是安全的; 2）75%的输入全氟化碳是 在腰椎液中回收; 3）再循环RDS-α原型可以a） 可靠地将调节的Revoxyn的pH、CO2和O2张力维持在 24 h的规格; B）24 h无人值守运行，不停机; c） 在压力>25 ℃的条件下成功阻止Revoxyn输送 流出限制。 拟定商业应用： 不可用