NCT04007081

Salivary Gland Autotransplantation for Treatment of XRT Induced Xerostomia

Salivary Gland Autotransplantation of Marrow Mesenchymal Stromal Cells for Treatment of Radiation-induced Xerostomia - FDA IND (Investigational New Drug) Enabling Studies

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Xerostomia
• Head and Neck Cancer

Interventions

Type	Name	Description
PROCEDURE	Bone Marrow Aspiration	collection of approximately 40 mL of bone marrow aspirate
DIAGNOSTIC_TEST	Ultrasound Imaging of Salivary Glands	Salivary gland size will be measured by ultrasound.
OTHER	Salivary Assay	Whole saliva production rates (sialometry) will be measured under unstimulated (first passive drool method) and stimulated (chewing gum) saliva collection conditions
OTHER	Quality of Life Instruments	Participants will self-assess with the following Quality of Life (QoL) surveys: University of Michigan Xerostomia related quality of life scale (XeQOL), the MD Anderson Dysphagia Index (MDADI), and the VAS xerostomia questionnaire.

Timeline

• Start date: 2019-10-18
• Primary completion: 2021-03-10
• Completion: 2021-03-10
• First posted: 2019-07-05
• Last updated: 2021-03-24

Locations

1 site across 1 country: United States