# Extending the Ischemic Penumbra in Large Vessel Occlusion Stroke

> **NIH NIH R41** · SHEARIT, LLC · 2024 · $490,049

## Abstract

Project Summary/Abstract
 Decades of neuroprotection clinical trials for large vessel occlusion (LVO) acute ischemic stroke (AIS) failed to translate
clinically. While these clinical trials were conducted, two treatments were approved for LVO AIS: 1) tPA thrombolysis within
6 hrs; and 2) Endovascular Arterial Thrombectomy (EAT) within 24 hrs of stroke onset were developed with strict
imaging guidelines and only 25% qualified for treatment. A tacit assumption in Neuroprotection is tissue to protect.
Neuroprotection clinical trials in AIS did not qualify patients by imaging. In "A New Paradigm for Neuroprotection
Clinical Trials in Acute Ischemic Stroke" (2) the new paradigm shifted to "freezing the penumbra and core" early
after stroke with imaging to qualify for tPA and EVT which could qualify 200,000 AIS in the US and 12.7M globally.
Shearit, LLC, promotes Lamiflo™ a 4000kDA drag reducing polymer (DRP) of polyethylene oxide (US Patent
9,763,975 B1, Sept. 19, 2017) for cerebrovascular disease. and cancer (U.S. Patent No. 10,792,304 issued
October 6, 2020). Lamiflo™ is the only treatment for AIS enhancing flow by the physical dynamics blood and red
blood cell (RBC) flow, not pharmacologically and does not rely on tissue or vascular viability. It converts turbulent
to laminar flow occurring at blood vessel bifurcations, vascular calcifications. It reduces near vessel wall cell free
layer, axial RBC flow, plasma skimming and increases capillary RBC density to improve tissue oxygenation.
Increased microvascular flow increases capillary endothelial wall shear rate, (highest in capillaries). Low
endothelial wall shear rate detected by the glycocalyx wreaks havoc on endothelial function--increased water
permeability, leukocyte endothelial adhesion and transendothelial transport, decreased nitric oxide synthesis, and
increased cytokine, chemokine and microglial activation. Specific Aim: Demonstrate that Lamiflo™ at plasma levels
of 5, and 10 ppm injected i.v.at 1 hr after transient middle cerebral artery occlusion (tMCAO) decreases the ischemic
penumbra and core volumes after 2.5 hrs of tMCAO by monofilament (MFO) and embolism thrombus occlusion
(EBO) without increasing the rate of hemorrhagic transformation (HT) and with 20% improved neurobehavioral
recovery. One year old Sprague Dawley (SD) male and female rats are treated with Lamiflo™ i.v. at 1 hr after tMCAO
by: 1) monofilament occlusion (MFO) or 2) embolus occlusion (EBO) with revascularization at 2.5 hrs, by MFO
filament withdrawal and rtPA infusion for EBO. Magnetic Resonance Imaging (MRI) at baseline, at 2.5 hrs before
reperfusion to quantitate Lamiflo™ reduction of penumbra and core volumes (Aim #1); and at 10 days recovery for
final core volumes (Aim #2). HT is quantitated by MRI susceptibility weighted imaging (SWI) and quantitative
susceptibility mapping (QSM) after 10 days recovery and Perl's iron stain. These studies will show the efficacy of
Lamiflo™in reducing the volume of core and penu...

## Key facts

- **NIH application ID:** 10820012
- **Project number:** 1R41NS129388-01A1
- **Recipient organization:** SHEARIT, LLC
- **Principal Investigator:** EDWIN M NEMOTO
- **Activity code:** R41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $490,049
- **Award type:** 1
- **Project period:** 2024-09-10 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10820012

## Citation

> US National Institutes of Health, RePORTER application 10820012, Extending the Ischemic Penumbra in Large Vessel Occlusion Stroke (1R41NS129388-01A1). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10820012. Licensed CC0.

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