Salivary Gland Autotransplantation for Treatment of XRT Induced Xerostomia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-18

Study Completion Date

2021-03-10

Brief Summary

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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.

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Detailed Description

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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

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Xerostomia Head and Neck Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Participants with Xerostomia

Salivary sample collection, quality of life survey, salivary gland imaging, bone marrow aspiration

Group Type EXPERIMENTAL

Bone Marrow Aspiration

Intervention Type PROCEDURE

collection of approximately 40 mL of bone marrow aspirate

Ultrasound Imaging of Salivary Glands

Intervention Type DIAGNOSTIC_TEST

Salivary gland size will be measured by ultrasound.

Salivary Assay

Intervention Type OTHER

Whole saliva production rates (sialometry) will be measured under unstimulated (first passive drool method) and stimulated (chewing gum) saliva collection conditions

Quality of Life Instruments

Intervention Type OTHER

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.

Interventions

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Bone Marrow Aspiration

collection of approximately 40 mL of bone marrow aspirate

Intervention Type PROCEDURE

Ultrasound Imaging of Salivary Glands

Salivary gland size will be measured by ultrasound.

Intervention Type DIAGNOSTIC_TEST

Salivary Assay

Whole saliva production rates (sialometry) will be measured under unstimulated (first passive drool method) and stimulated (chewing gum) saliva collection conditions

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Bone Marrow Collection sialometry

Eligibility Criteria

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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

* No history of radiation to the salivary glands
* Willing and able to give informed consent