Salivary Gland Autotransplantation for Treatment of XRT Induced Xerostomia

Status Completed

Clinical Trial Summary

Xerostomia, or dry mouth, is a common side effect of head neck radiation. Current treatment options for radiation-induced xerostomia are generally supportive in nature. Most of these supportive interventions do not reverse xerostomia and are palliative in intent. The investigators propose that autotransplantation of marrow-derived mesenchymal stromal cells (MSCs) in salivary glands post-RT or post-chemoradiation therapy (CRT) may provide an innovative remedy to treat xerostomia and restore quality of life. Participants can expect to be on study for up to 6 months.

Clinical Trial Description

This feasibility study will analyze the salivary composition, salivary viscoelasticity, salivary gland US, and QoL surveys of participants without head and neck cancer (HNC) to determine standard values. The investigators will then compare this to the salivary composition and viscoelasticity of participants with treated HNC. Additionally, the investigators will examine the paracrine factors of marrow MSCs in order to prove a hypothesis that paracine factors constitutively expressed by marrow MSCs [Wnts, fibroblast growth factors (FGFs), GDNF and others] will directly influence the biology of dormant salivary gland stem cells following intraglandular transplantation and allow for functional recovery following RT. Primary Objective - To determine the feasibility of in vitro expansion of marrow-derived MSCs from HNC patients to >50 million cells. Secondary Objectives - To assess the stability of salivary function in HNC patients using quality-of-life (QoL) questionnaires and salivary composition analysis. - To assess the stability of salivary gland size as measured by ultrasound. Correlative Objectives - To compare assess the secretome profile of MSCs from HNC patients treated with radiation or, chemoradiation, or previously untreated. - To compare the salivary composition, viscoelasticity, salivary gland ultrasound, and QoL of HNC patients to non-HNC patients ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04007081
Study type	Interventional
Source	University of Wisconsin, Madison
Contact
Status	Completed
Phase	N/A
Start date	October 18, 2019
Completion date	March 10, 2021

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