# Regeneration of Multi-Layered Vocal Fold Mucosa

> **NIH NIH R01** · UNIVERSITY OF WISCONSIN-MADISON · 2020 · $586,422

## Abstract

Severe vocal fold (VF) mucosal injury and its associated voice impairment (dysphonia) is a debilitating and 
challenging clinical problem with few treatment options, none of which are consistently effective. In patients 
with such tissue impairment or loss, an engineered VF mucosa would provide a biomechanically appropriate 
tissue graft for voice restoration. During our previous funding cycle, we engineered such a VF mucosa via 
organotypic culture of primary vocal fold fibroblasts and epithelial cells from human donors. In a series of 
preclinical experiments, the engineered mucosa recapitulated the structure and physiologic function of native 
human tissue. In the current application, we propose a natural extension of our prior work by advancing 
characterization of the in vitro tissue engineering process at the biological system level (Aim 1), studying 
remodeling and the adaptive immune response to the engineered mucosa following in vivo heterotopic 
implantation (Aim 2), and studying long-­term physiologic and immunologic outcomes following in vivo 
orthotopic implantation (Aim 3). These experiments will generate important preclinical safety and efficacy data. 
We will combine the planned experimental work with regulatory and clinical manufacturing milestones (Aim 4), 
with a final goal of holding a pre-­Investigational New Drug meeting with the FDA by the end of the grant. The 
tissue engineering technology outlined in this application has the potential to transform treatment of the most 
recalcitrant VF tissue disorders encountered in the clinic.

## Key facts

- **NIH application ID:** 9982291
- **Project number:** 5R01DC010777-10
- **Recipient organization:** UNIVERSITY OF WISCONSIN-MADISON
- **Principal Investigator:** Nathan Welham
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $586,422
- **Award type:** 5
- **Project period:** 2010-04-01 → 2022-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9982291

## Citation

> US National Institutes of Health, RePORTER application 9982291, Regeneration of Multi-Layered Vocal Fold Mucosa (5R01DC010777-10). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9982291. Licensed CC0.

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