Evaluation of Immunomodulatory Device for Early Treatment of TBI
Novel therapy which modulates the excessive activation state of circulating inflammatory cells in secondary brain injury
Project at a Glance
Product Type:
Therapeutic Device
Project Start Date:
7/1/2022
Principal Investigators:
H. David Humes, MD
Thomas Sanderson, PhD
Joseph Wider, PhD
Solution Sheet:
Available soon
Funding History:
$185,205 in non-dilutive funding • 2022 $185,205 Massey Grand Challenge • Substantial departmental, school and center based support
Overview
TBI, as well as the ischemic reperfusion injury (IRI) following trauma resuscitation, activates the innate immunologic system locally and systemically, initiating both beneficial and detrimental effects on the degree of brain injury and survivability. The resulting inflammation promotes a vicious cycle of microvascular dysfunction, blood brain barrier disruption, cerebral edema and neuronal cell death.
The project team will evaluate a novel immunomodulatory therapy, the selective cytopheretic device (SCD), which modulates the excessive activation state of circulating inflammatory cells without 1.) complete removal of leukocyte subpopulations or 2.) administration of systemic pharmacologic agents for suppression of the proinflammatory cascade,thus avoiding potential undesired side effects of increased susceptibility to infections and disruption of the natural reparative phase of tissue repair, which the team believes could drastically improve care for TBI.
Image credit: Shutterstock
Significant Need
Clinical evidence for inflammation driving secondary brain injury is mounting with observational studies associating elevation in pro-inflammatory markers with important clinical variables, yet pharmacologic anti-inflammatory interventions have not yet proven effective in improving outcome after TBI.
Due to the complexity of the immune system, simply blocking the inflammatory cascade by targeting single factors is not likely to be successful. Infection is a major complication to TBI recovery; therefore, therapies must be carefully evaluated to ensure they are immunomodulatory rather than immunosuppressive.
Competitive Advantage
The SCD technology is well positioned for rapid advancement to the clinic for TBI, having a demonstrated and excellent safety profile in previous FDA approved clinical trials.
Funding Organization(s)
Publications
None at this time