# Human Schwann Cell-Derived Exosome Treatment for Traumatic Brain Injury

> **NIH NIH R37** · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · 2023 · $407,507

## Abstract

Traumatic brain injury (TBI) produces a spectrum of pathophysiological and behavioral consequences that
severely affect the quality of life of people living with these disorders, family members and caregivers. The
successful translation of therapeutic interventions to the clinic to improve neurological outcomes through
multicenter TBI trials is yet to be achieved. There is therefore a great need for continued research into novel
post-traumatic therapeutic strategies that may target multiple cellular and molecular mechanisms of cell
vulnerability, death and repair. We have developed FDA-approved protocols to isolate and grow millions of
human Schwann cells (hSC) and have most recently received a compassionate use Investigational New Drug
to test hSC-derived exosomes (hSC-Exos) for a neurodegenerative disorder. Based on supportive preliminary
data, we propose to conduct a series of critical studies to evaluate the optimal dose and therapeutic window for
hSC-Exos treatment on structural, biochemical, and long-term behavioral outcomes using an established model
of severe TBI. Our overall hypothesis is that intravenous administration of hSC-Exos after TBI will target multiple
secondary injury mechanisms as well as reparative processes leading to improved histopathological and
longterm behavioral outcomes. We propose that a major mechanism for this benefit will include anti-inflammatory
effects that will promote cytoprotection as well as enhance the opportunity for endogenous reparative processes.
We also suggest that this approach can be successfully translated into humans based on the results of this study
as our approach of isolating the hSC-Exos has been approved by the FDA. Specific Aim 1 will evaluate the dose-
response effects (3 doses) of the hSC-Exos in sham operated and TBI animals. Specific Aim 2 will then evaluate
the optimal dose of hSC-Exos on the therapeutic window on behavioral and histopathological outcomes. In
Specific Aim 3 we will measure temporal and regional pattens of inflammatory mediators including inflammasome
proteins in brain and blood samples after hSC-Exos treatment. To specifically study mechanisms of action,
Specific Aim 4 will evaluate the hSC-Exos cargo for the first time using state-of-the-art miRNA sequenceing and
informatic approaches. For all studies, we will utilize the penetrating ballistic-like brain injury model in male and
female Sprague Dawley rats, clinically relevant outcome measures, biochemical analyses and include strateges
to enhance scientific rigor and reproducibility. For the assemment of the hSC-Exos cargo, we will work with an
established company to conduct next generation RNA sequencing and mRNA libraries, document the various
molecular mechanisms of action and test cause and effect relationships while providing new knowledge to this
field of neurotrauma. The results of this proposal will have a significant impact on the field of neurotrauma by
investigating a new cell based neuroprotective therap...

## Key facts

- **NIH application ID:** 10714644
- **Project number:** 1R37NS133195-01
- **Recipient organization:** UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
- **Principal Investigator:** W Dalton Dietrich
- **Activity code:** R37 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $407,507
- **Award type:** 1
- **Project period:** 2023-08-01 → 2027-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10714644

## Citation

> US National Institutes of Health, RePORTER application 10714644, Human Schwann Cell-Derived Exosome Treatment for Traumatic Brain Injury (1R37NS133195-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10714644. Licensed CC0.

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