Neuroprotection with Intranasal Insulin after TBI

A novel treatment strategy for secondary traumatic brain injury using high-dose intranasal insulin.


Project at a Glance

Product Type:
Therapeutic

Project Start Date:
7/1/2019

Principal Investigators: Thomas Sanderson, PhD
Robert Neumar, MD, PhD
Joseph Wider, PhD

Solution Sheet:
Download Solution Sheet (PDF)

Funding History:
$99,839 in non-dilutive funding • 7/1/2019 $99,839 Massey Grand Challenge


Overview

A team of University of Michigan researchers aims to develop a novel treatment strategy using high-dose intranasal insulin to address the early injury mediated neurometabolic pathological cascade.

High-dose intranasal insulin (HD-IN-I) reduces brain lesion volume and improves functional outcome after TBI in rats. This therapeutic effect is achieved without causing hypoglycemia. If HD-IN-I is ultimately proven effective in humans, the potential impact could be dramatic.

Currently, the goal of this prospective project is to collect proof-of-principal evidence of the efficacy of HD-IN-I in treating TBI. The next step necessary to move toward human clinical trials will be to demonstrate that HD-IN-I improves functional outcome in a clinically relevant large animal model of TBI.

Significant Need

Surgical decompressive craniectomy is performed in TBI patients to reduce intracranial pressure (ICP); however, this intervention was not associated with more favorable out-comes. Moreover, intracranial pressure guided treatment, a widely used standard care for TBI patients, yielded no superior outcomes.

While animal models have shown promising outcomes with hypothermic-targeted temperature management (aka therapeutic hypothermia), POLAR trial tested the impact of hypothermia (33-35°C) following TBI with no benefit. To date, no pharmacological interventions (Mannitol, Calcium channel blockers, corticosteroids, VPA) have been successful in improving outcomes.

In summary, current translational approaches aimed at supportive care of secondary brain injuries have been unsuccessful in improving TBI related deaths.

Competitive Advantage

The intranasal delivery route makes it feasible for paramedics or combat medics to initiate therapy within minutes of injury, and the safety profile is such that monitoring for hypoglycemia would not be required. IN-I therapy is already in clinical trials for Alzheimer’s disease and stroke, which demonstrates translational feasibility.


Funding Organization(s)


Publications

None at this time