# Planning a phase I study of minor salivary gland derived autologous MSCs for prevention of long-term radiation induced xerostomia

> **NIH NIH R34** · UNIVERSITY OF WISCONSIN-MADISON · 2024 · $147,680

## Abstract

Project Abstract
Dry mouth is a significant side-effect of radiation therapy for head and neck cancer patients. Several factors
contribute to dry mouth. Decreased production of saliva is called hyposalivation. Poor quality and function of
saliva is called salivary dysfunction. Together, these cause xerostomia, or what a patient experiences as
simply dry mouth. Xerostomia can lead to tooth decay, infections, difficulty speaking, impaired swallowing, poor
nutrition, and has a significant negative effect on quality of life. Doctors recommend that patients suck on hard
candy, chew gum, use saliva substitutes, and/or carry a water bottle with them at all times. None of these are
particularly effective. Our long-term goal is to prevent the development of long-term radiation-induced dry
mouth to improve the quality of life for patients with head and neck cancer. We seek to achieve this goal by
providing convincing evidence that innovative cellular therapies can safely and significantly prevent the
development of long-term salivary gland dysfunction. The team of investigators tackling this project is uniquely
suited to complete the work. Success would lead directly to the next phase of clinical testing. We have
expertise in caring for head and neck cancer patients, developing minor salivary gland derived mesenchymal
stromal cells (MSCs) as cellular therapies, and studying salivary function. The overall objective of this
application is to plan and prepare for a Phase 1 trial to test the safety and tolerability of IFN-g pre-licensed
minor salivary gland derived MSCs for prevention of radiation-induced xerostomia in head and neck cancer
patients. To achieve our goals, we propose a milestone-based project in which we will work closely with the
NIH and FDA to finalize study design for a Phase 1 safety and tolerability study, complete the clinical trial
protocol, and submit regulatory documents in Aim 1. In Aim 2, we will complete all necessary milestones to
activate the proposed clinical trial including safety systems, data systems, and site staff and facility preparation
to ensure a smooth opening to the planned clinical trial.

## Key facts

- **NIH application ID:** 10910120
- **Project number:** 5R34DE033042-02
- **Recipient organization:** UNIVERSITY OF WISCONSIN-MADISON
- **Principal Investigator:** Randall J. Kimple
- **Activity code:** R34 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $147,680
- **Award type:** 5
- **Project period:** 2023-09-01 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10910120

## Citation

> US National Institutes of Health, RePORTER application 10910120, Planning a phase I study of minor salivary gland derived autologous MSCs for prevention of long-term radiation induced xerostomia (5R34DE033042-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10910120. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*