Salivary Gland Autotransplantation for Treatment of XRT Induced Xerostomia

University of Wisconsin (UW)

Status

Completed

Conditions

Xerostomia

Head and Neck Cancer

Treatments

Diagnostic Test: Ultrasound Imaging of Salivary Glands

Other: Salivary Assay

Procedure: Bone Marrow Aspiration

Other: Quality of Life Instruments

Study type

Interventional

Funder types

Other

Identifiers

NCT04007081

A533300 (Other Identifier)

UW19009

SMPH/HUMAN ONCOLOGY/HUMAN ONCO (Other Identifier)

Protocol Version 7/24/2020 (Other Identifier)

2019-0497 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment

12 patients

Sex

All

Ages

18 to 89 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participants ≥2 years from completion of chemoradiation therapy or radiation therapy (N=6) with subjective complaint of xerostomia or with no diagnosis of HNC (N=5)
Karnofsky ≥ 60, participant eligible for bone marrow aspirate with wakeful anesthesia
Not pregnant
Willing and able to give informed consent
non-HNC participants only need to meet the following applicable inclusion criteria
- No history of radiation to the salivary glands
- Willing and able to give informed consent