# Neural Stem Cell Extracellular Vesicle Treatment for Traumatic Brain Injury

> **NIH NIH R41** · ARUNA BIOMEDICAL, INC. · 2022 · $346,150

## Abstract

Project Summary/Abstract
 Traumatic brain injury (TBI) is a universal health concern and is known as a “silent epidemic”. Each year
in America, 2.53 million patients visit the emergency department after suffering a TBI of which 56,800 die and
over 288,000 require hospitalization, rehabilitation programs, and long-term supportive care. Although the
primary TBI event is typically acute, subsequent secondary injury responses (neuroinflammation) and chronic
tissue loss often result in functional deficits that last a lifetime. Presently, there are no neuroprotective or
regenerative Food and Drug Administration approved TBI treatments. Aruna Bio has recently developed a novel
neuroprotective and regenerative neural stem cell extracellular vesicle (NSC EV) product called AB126™ that
may be used to treat TBI. AB126™ has demonstrated multimodal therapeutic efficacy in divergent species (aged
mouse, rat, pig) and neural injury models (TBI, stroke). In TBI rodent models, AB126™ reduced lesion sizes,
enhanced endogenous neurogenesis and angiogenesis, and rapidly attenuated motor function impairments.
Large animal testing has been repeatedly identified by academic, industry, and government agencies as a key
de-risking step in TBI therapeutic development. To this end, this proposal outlines FDA enabling studies in a pig
controlled cortical impact TBI model using clinically relevant assessment tools to evaluate the efficacy and safety
of AB126™ as a treatment for TBI. The successful completion of this study will provide key information pertaining
to AB126™ dosage, therapeutic effects on TBI pathophysiology (edema, hemorrhage) and functional outcomes,
toxicity, and potential adverse side effects that will serve as the basis for an IND submission and future clinical
trials.

## Key facts

- **NIH application ID:** 10483956
- **Project number:** 1R41NS122704-01A1
- **Recipient organization:** ARUNA BIOMEDICAL, INC.
- **Principal Investigator:** STEVEN L STICE
- **Activity code:** R41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $346,150
- **Award type:** 1
- **Project period:** 2022-06-01 → 2025-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10483956

## Citation

> US National Institutes of Health, RePORTER application 10483956, Neural Stem Cell Extracellular Vesicle Treatment for Traumatic Brain Injury (1R41NS122704-01A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10483956. Licensed CC0.

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