# In vitro and in vivo assessments of xenogeneic cranial dura mater and naturally derived commercial dural grafts

> **NIH NIH R01** · UNIVERSITY OF FLORIDA · 2023 · $394,850

## Abstract

Project Summary:
One of dura mater’s most important functionalities is to keep Cerebral Spinal Fluid (CSF) inside
of the cranial cavity. To avoid life-threatening complications there exists a need for effective and
reliable dural graft replacements post-surgery. A broad selection of dura grafts exists; however,
no consensus has been reached on which graft is best suited to avoid dura mater ruptures and
adverse immunological responses. Naturally derived and synthetic grafts are most used as dura
replacements in the clinic. Native ECM constructs, when properly treated and handled, have the
potential to preserve the overall architecture of the tissue matrix. Decellularized constructs have
been shown to provide structural support, adhesion sites for cell attachment, and growth factors
for cell proliferation. However, the commercially available naturally derived matrices undergo
extensive processing, including lyophilization, which may be cause for clearing of relevant ECM
proteins needed for sustained tissue health. The research question we propose to answer in this
study is Do acellular xenogeneic dural grafts elicit a less deleterious immune response than
naturally derived commercial grafts and maintain structural integrity over the long term for in vivo
studies?
We will examine the rigor of graft sealing strength, risk of infection and/or inflammation, and
wound healing/tissue incorporation in vitro and in vivo within a rat model. Our central hypothesis
is that native xenogeneic ECM grafts with multiple ECM proteins will perform better than
the naturally derived (commercial) ECM dural grafts due to their improved mechanical and
immunological responses assayed in vitro and in vivo. This application focuses on two, multi-
objective specific aims. In Aim 1 we will perform in vitro studies focused on the mechanical
response, structural integrity, immunological response, and scar formation associated with four
grafts. We will examine two naturally derived, commercial dural grafts, Biodesign®, and
Lyoplant®, and two tissue-based grafts directly from the source—porcine dura, and cadaveric
human dura. In Aim 2 we will investigate, in vivo, the border integrity of all grafts by quantifying
leakage of CSF. Additionally, we will assess scar formation and immune infiltration in our
xenogeneic vs. naturally derived commercially available grafts. The knowledge gained from this
work will provide empirical knowledge on the role of tissue-derived xenogeneic grafts for dural
replacement. Increased surgeon confidence will enable appropriate graft selection for patients,
reduced operative morbidity and mortality following cranial procedures.

## Key facts

- **NIH application ID:** 10692640
- **Project number:** 5R01NS122939-02
- **Recipient organization:** UNIVERSITY OF FLORIDA
- **Principal Investigator:** Lakiesha Nicole Williams
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $394,850
- **Award type:** 5
- **Project period:** 2022-09-01 → 2027-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10692640

## Citation

> US National Institutes of Health, RePORTER application 10692640, In vitro and in vivo assessments of xenogeneic cranial dura mater and naturally derived commercial dural grafts (5R01NS122939-02). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10692640. Licensed CC0.

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