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SanFlow: A Therapeutic Agent for Use in the Field for Traumatic Brain Injury

Award Information
Agency: Department of Defense
Branch: Defense Health Program
Contract: W81XWH19C0022
Agency Tracking Number: H2-0406
Amount: $999,817.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: DHA17-011
Solicitation Number: 2017.1
Timeline
Solicitation Year: 2017
Award Year: 2019
Award Start Date (Proposal Award Date): 2018-12-03
Award End Date (Contract End Date): 2021-05-02
Small Business Information
2329 N. Career Ave, Sioux Falls, SD, 57107
DUNS: 080471754
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 Carleton Hsia
 (949) 272-6222
 cjchsia@yahoo.com
Business Contact
 Bohdan Soltys
Phone: (905) 616-3016
Email: bohdan.soltys@gmail.com
Research Institution
N/A
Abstract
An ideal therapeutic for traumatic brain injury (TBI) accompanied by hemorrhagic shock (HS) should serve both as a resuscitation fluid to restore perfusion pressure while directly protecting the brain from secondary injury. Previous work in mice demonstrated that SanFlow is more effective than crystalloid or whole blood in restoring arterial pressure after TBI+HS and reduces neurodegeneration in the hippocampus. In Phase I, we found that resuscitation with SanFlow was superior to electrolytes in restoring arterial pressure and preserving hippocampal viable neurons in a guinea pig model of TBI+HS. In Phase II, we will evaluate the efficacy of SanFlow in a pig model, a large animal with a gyrencephalic brain. The first objective is to manufacture 30 L of SanFlow. The second objective is to evaluate three doses of SanFlow during resuscitation from TBI+HS on 4-day outcome of neuroinflammation, blood-brain barrier permeability, subacute neurodegeneration, and axonal injury. Using the optimal dose of SanFlow, the third objective is ascertain stable protection of neurons and axons over 15 days of recovery. These studies will inform whether SanFlow is capable of mitigating secondary brain injury over a 4-day period, and whether this treatment provides long-term neuroprotection rather than simply delaying neurodegeneration.

* Information listed above is at the time of submission. *

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