Salivary Gland Autotransplantation for Treatment of XRT Induced Xerostomia
Condition: Xerostomia; Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms; Xerostomia
Study type: Interventional

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
    

Intervention name(s): Bone Marrow Aspiration; Ultrasound Imaging of Salivary Glands; Salivary Assay; Quality of Life Instruments
Intervention type(s): Procedure; Diagnostic Test; Other; Other
Intervention description(s): collection of approximately 40 mL of bone marrow aspirate; Salivary gland size will be measured by ultrasound.; Whole saliva production rates (sialometry) will be measured under unstimulated (first passive drool method) and stimulated (chewing gum) saliva collection conditions; 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.
Other intervention name(s): Bone Marrow Collection; sialometry
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Dry Mouth; MSC; mesenchymal stem cells; adult stem cells; head and neck cancer; salivary gland; radiation; HNC