# Amnion cell secretome mediated therapy for traumatic brain injury

> **NIH VA I01** · JAMES A. HALEY VA MEDICAL CENTER · 2023 · —

## Abstract

Individuals who have sustained a traumatic brain injury (TBI) have emerged as a significant cause of death
to the Warfighters in Iraq and Afghanistan. Whether mild, moderate or severe brain injury, the level of
assessment and standard of care provided to the Veteran Population is in need of enhancement. To this
end, to expand upon the limited knowledge of the long-term effects of traumatic brain injury, we propose to
use our animal model of repetitive-mTBI (r-mTBI) and test a novel treatment to treat/prevent the progression
of the chronic pathology following r-mTBI.
We hypothesize that a delayed and chronic intranasal treatment with ST266 will mitigate the functional and
neuropathological consequences of r-mTBI by improving, cognition, anxiety, sensory and motor function,
and with modulation of neuroinflammation in the CNS and in its periphery. ST266 is a proprietary secretome
produced by Noveome Biotherapeutics, Inc that contains hundreds of biologically active proteins and other
factors that have been shown to be crucial to neuroprotection, modulation of inflammation, cell recovery
and healing. The overarching aim of the proposed study is to investigate and refine our understanding of
the chronic effects of r-mTBI, using our mouse model of r-mTBI. In addition, this project will investigate the
independent association of sex with outcome after r-mTBI with or without treatment with ST266.
In the first aim, male and female animals will be exposed to five mTBIs, and then treated daily with a Low
or High dose of ST266 delivered intranasally, or saline for a period of 4 months starting at 6 or 18 months
post-last injury. The neurobehavioral performance will then be evaluated at both 10- and 22-months post-
injury. In the second aim, neuropathological and biochemical analyses will be evaluated at the same time
point. Finally, in the third aim, blood biomarkers associated with neurobehavioral recovery such a BDNF or
other pro-inflammatory cytokines will be evaluated acutely and chronically post r-mTBI and pre and post
ST266 treatment. For each aim, we will evaluate the same outcome measures in female and male mice
who have undergone our 5-injury paradigm to identify sex-specific differences. We believe these findings
will have broad applicability in TBI research, as the data generated in this study will further the
understanding of the complex interaction between ST266 and TBI, and furthermore, we believe this study
will provide novel insight into TBI-related pathology and cognitive issues over time in both male and female
Veterans.
By assessing nuanced aspects of neurobehavioral and pathological deficits, we will provide a framework
from which informed decisions can then be made about the cellular and molecular mechanisms that are
most important to target to reduce long term TBI-related pathology, and furthermore, which therapeutic
intervention strategy best suits the patient. Within 30 months from the start date of this project, we will be
able to de...

## Key facts

- **NIH application ID:** 10746655
- **Project number:** 1I01RX004245-01A2
- **Recipient organization:** JAMES A. HALEY VA MEDICAL CENTER
- **Principal Investigator:** Benoit Christian Mouzon
- **Activity code:** I01 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2023
- **Award amount:** —
- **Award type:** 1
- **Project period:** 2023-10-01 → 2027-09-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10746655

## Citation

> US National Institutes of Health, RePORTER application 10746655, Amnion cell secretome mediated therapy for traumatic brain injury (1I01RX004245-01A2). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10746655. Licensed CC0.

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