DIRECT CEREBRAL OXYGENATION FOR ISCHEMIC STROKE

描述(摘自申请者的摘要)：神经治疗公司(NFL) 正在开发一种含全氟碳的人工脑脊液 (Revoxn)可以将氧气和其他营养物质直接输送到脑组织 即使血管闭塞，脑血流因缺血而受损 中风是一种“脑溢血”。临床前研究表明，脑室 用Revoxn灌流可将脑梗塞体积缩小90%并逆转丢失 脑电活动。 在此Fast Track SBIR应用程序的第一阶段中，NTI将：1)确定 单次经脑室-腰椎给药的Revoxn灌注 对于重度半球缺血性卒中患者，路线是安全的；2) 确定在大脑发育过程中Revoxn的组成变化的程度 人体灌流；3)设计、制造和在实验室工作台上测试 一种适用于临床前安全性的原型循环灌注器 在体内进行测试。如果1)Revoxn单次通过，将论证可行性 灌流系统在人体内是安全的；2)75%的输入全氟碳是 在腰液中恢复；3)循环RDS-α原型可以a) 可靠地将调节的Revoxn的pH、C02和02张力维持在 规格为24小时；b)24小时无人值守运行；c) 成功防止在压力和25托的条件下交付Revoxn 流出限制。 建议的商业应用： 不可用

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