Cerebral edema subsequent to stroke and traumatic brain injury (TBI) is a life-threatening complication that is refractory to conventional treatments in many patients. The proposed research will develop a novel tissue ultrafiltration (TUF) therapy for use in humans with brain edema. Bench studies will identify materials (ultrafiltration fibers, bonding agents, supports) and operational parameters (extraction methods, pressure magnitudes) providing optimal fluid flux via TUF probes during in vitro and ex vivo brain tissue testing. Large-scale, single- or multiple-fiber TUF probes will be tested for ability to acutely (6h) or chronically (24h) extract edematous fluid, reduce intracranial pressure (ICP), and/or reduce tissue water content in a feline model of cyrogenic cortical injury. Larger scale TUF probes will be tested for fluid extraction and ability to reduce edema and ICP in a nonhuman primate model of stroke, using comuted tomography and magnetic resonance imaging to measure cerebral blood flow and tissue water distributions. Successful development and marketing of this proprietary methodology could significantly reduce morbidity and mortality after human stroke or TBI.
The Company plans to manufacture and market ultrafiltration systems to treat cerebral edema in patients with severe TBI, stroke and other neurological disorders. The contemplated product is a self contained unit with tissue ultrafiltration catheters, fluid collection lines and collection chambers for containment of ultrafiltrate.
