Neural Stem Cell Extracellular Vesicle Treatment for Traumatic Brain Injury - 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.
