<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04489732</url>
  </required_header>
  <id_info>
    <org_study_id>2020-1290</org_study_id>
    <secondary_id>A533300</secondary_id>
    <secondary_id>SMPH/HUMAN ONCOLOGY/HUMAN ONCO</secondary_id>
    <secondary_id>UW20025</secondary_id>
    <secondary_id>NCI-2021-00070</secondary_id>
    <secondary_id>1UG3DE030431-01</secondary_id>
    <secondary_id>Protocol Version 10/7/2021</secondary_id>
    <secondary_id>Head &amp; Neck SPORE</secondary_id>
    <nct_id>NCT04489732</nct_id>
  </id_info>
  <brief_title>MSC in Patients With Xerostomia Post XRT in Head and Neck Cancer</brief_title>
  <official_title>Pilot Study of Mesenchymal Stromal Cells in Patients With Xerostomia After Radiation Therapy for Head and Neck Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Wisconsin Carbone Cancer Center (UWCCC)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Dental and Craniofacial Research (NIDCR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single center pilot study designed to determine the safety and tolerability of&#xD;
      autologous bone marrow-derived Mesenchymal Stromal Cells (MSCs) in patients with xerostomia&#xD;
      (dry mouth) after undergoing radiation therapy (XRT) for head and neck cancer (HNC). Up to 12&#xD;
      participants will be enrolled and can expect to be on study for up to 2 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Following the completion of screening/baseline procedures, and written consent, eligible&#xD;
      participants will undergo bone marrow aspirate in order to obtain MSCs.&#xD;
&#xD;
      The MSC Investigational Medicinal Product (IMP) (dose level 0, n=6, staggered) will be&#xD;
      injected into one submandibular gland under local anesthesia, in the gland that received the&#xD;
      lowest radiation dose. Patients with only one submandibular gland will be ineligible.&#xD;
&#xD;
      All participants will be called by a study coordinator 3 days (+/- 2 days) after injection to&#xD;
      assess pain and will have a phone visit with a physician 1 week (+/- 2 days) after injection&#xD;
      during which the investigator will assess pain and ask about the area of injection regarding&#xD;
      redness and/or swelling. All participants will complete a pain diary with daily entries over&#xD;
      the first month to record the occurrence and severity of pain using a 0-10 visual analog&#xD;
      scale and occurrence and severity of other adverse events (e.g., redness, swelling, warmth,&#xD;
      tenderness, rash, pruritis, nausea, vomiting, fatigue). Participants will also keep a log of&#xD;
      all pain medications taken including both narcotic and non-narcotic medications (e.g.&#xD;
      ibuprofen, acetaminophen, etc.) for the first month. Participants will complete 5 follow-up&#xD;
      visits over the course of 24 months - at 1, 3, 6, 12, and 24 months following the&#xD;
      intervention. Salivary collection for analysis as well as QoL surveys will be obtained at&#xD;
      these visits.&#xD;
&#xD;
      Dose Reduction:&#xD;
&#xD;
        -  If dose limiting toxicity (DLT) in less than or equal to 1 participant (n=6&#xD;
           participants, staggered at least 14 days), Dose Level 0 will be recommended as starting&#xD;
           dose for subsequent trial.&#xD;
&#xD;
        -  If DLT in greater than 1 participant, dose level -1 will be administered, staggered at&#xD;
           least 14 days in n=6 participants.&#xD;
&#xD;
        -  If DLT in this cohort is in less than or equal to 1 participant, Dose Level -1 will be&#xD;
           recommended as starting dose for subsequent trial. If DLT in greater than or equal to 2&#xD;
           participants, study will be stopped.&#xD;
&#xD;
      Primary Objective&#xD;
&#xD;
        -  To evaluate the safety and tolerability of MSCs for subjects with xerostomia after&#xD;
           radiation therapy for HNC.&#xD;
&#xD;
      Secondary Objectives&#xD;
&#xD;
        -  To evaluate the efficacy of MSCs for treatment of xerostomia and salivary hypofunction&#xD;
           via quality-of-life (QoL) questionnaires, salivary amount, and salivary compositional&#xD;
           analysis.&#xD;
&#xD;
        -  To assess the imaging characteristics in HNC patients after MSC injection using&#xD;
           ultrasound.&#xD;
&#xD;
        -  To assess the feasibility of a future Phase 1 dose-escalation study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 18, 2022</start_date>
  <completion_date type="Anticipated">May 2024</completion_date>
  <primary_completion_date type="Actual">November 22, 2022</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>single-center, open-label, non-randomized, non-placebo controlled, single-group assignment, pilot study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of subjects experiencing dose limiting toxicity (DLT)</measure>
    <time_frame>up to 1 month post injection (up to 3 months from consent)</time_frame>
    <description>Dose limiting toxicity is defined as: submandibular pain &gt; 5 on a standard 10-point pain scale of 0-10 at 1-month after MSC injection OR any serious AE OR any of the selected toxicities listed per protocol within one-month post-injection.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Saliva production rate</measure>
    <time_frame>baseline (up to 8 weeks before injection), 1, 3, 6, 12, and 24 months post-injection</time_frame>
    <description>Whole saliva production rates will be measured under unstimulated and stimulated saliva collection conditions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Saliva composition analysis: Change in salivary pH</measure>
    <time_frame>baseline (up to 8 weeks before injection), 1, 3, 6, 12, and 24 months post-injection</time_frame>
    <description>Salivary pH will be measured using a pH meter. The normal range of saliva pH is 6.2-7.6 .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Saliva composition analysis: Change in total protein concentration in saliva</measure>
    <time_frame>baseline (up to 8 weeks before injection), 1, 3, 6, 12, and 24 months post-injection</time_frame>
    <description>ELISA will be used to quantify total protein concentration in saliva. The normal range of total protein in saliva is 2-5 mg/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Saliva composition analysis: Change in amylase concentration in saliva</measure>
    <time_frame>baseline (up to 8 weeks before injection), 1, 3, 6, 12, and 24 months post-injection</time_frame>
    <description>The enzyme-linked immunosorbent assay (ELISA) will be used to quantify amylase concentration in saliva. The normal range of amylase concentration in saliva is 10-150 U/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Saliva composition analysis: Change in mucin concentration in saliva</measure>
    <time_frame>baseline (up to 8 weeks before injection), 1, 3, 6, 12, and 24 months post-injection</time_frame>
    <description>ELISA will be used to quantify mucin concentration in saliva.The normal range of mucin concentration in saliva is 1,000-3,000 ug/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in The University of Michigan Xerostomia Related Quality of Life (XeQOL) score</measure>
    <time_frame>baseline (up to 8 weeks before injection), 1, 3, 6, 12, and 24 months post-injection</time_frame>
    <description>The University of Michigan Xerostomia Related Quality of Life (XeQOL) scale is a validated patient-reported assessment 15 item scale with 4 domains: physical functioning, pain/discomfort, personal/psychologic functioning, and social functioning. Participants will answer the questions on a scale of 1-5 (not a all, a little, somewhat, quite a bit, very much) for every item. Higher scores represent greater degree of symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in The MD Anderson Dysphagia Index (MDADI) score</measure>
    <time_frame>baseline(up to 8 weeks before injection), 1, 3, 6, 12, and 24 months post-injection</time_frame>
    <description>The MDADI is a 20-item questionnaire designed for evaluating the impact of dysphagia on the quality of life of patients with head and neck cancer. The MDADI score ranges from 20-100 with a lower scale representing worse dysphagia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Visual Analogue Scale (VAS) xerostomia score</measure>
    <time_frame>baseline (up to 8 weeks before injection), 1, 3, 6, 12, and 24 months post-injection</time_frame>
    <description>A Visual Analogue Scale questionnaire for subjective assessment of salivary dysfunction. The VAS xerostomia questionnaire is an 8-item questionnaire that provides a validated measure of the perception of dry mouth. Participants will be asked to mark their responses to each item by placing a vertical line on the 100-mm horizontal scale. The VAS ranges from 8-80 with a lower scale representing less dysphagia/symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in salivary gland size</measure>
    <time_frame>baseline (up to 8 weeks before injection), 3, 6, and 12 months post-injection</time_frame>
    <description>Salivary gland size measured by ultrasound imaging</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in salivary gland stiffness measured by shear wave velocity</measure>
    <time_frame>baseline (up to 8 weeks before injection), 3, 6, and 12 months post-injection</time_frame>
    <description>Salivary gland stiffness (fibrosis) will be measured by acoustic radiation force impulse imaging. Evaluators will be blinded to the time point of evaluation (pre- or post- MSC injection)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant Drop out Rate</measure>
    <time_frame>up to 24 months post-injection (up to 26 months from consent)</time_frame>
    <description>Study feasibility will in part be measured by participant drop out rate.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Xerostomia Following Radiotherapy</condition>
  <arm_group>
    <arm_group_label>Treatment with MSCs</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single dose of MSCs injected into the submandibular glands of patients with radiation-induced xerostomia</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Autologous bone-marrow derived, interferon gamma stimulated mesenchymal stromal cells</intervention_name>
    <description>Single dose, starting at&#xD;
Dose Level 0: 10 x 10^6 injected into one submandibular gland on Day 1</description>
    <arm_group_label>Treatment with MSCs</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willing to provide informed consent&#xD;
&#xD;
          -  Willing to comply with all study procedures and be available for the duration of the&#xD;
             study&#xD;
&#xD;
          -  Histological diagnosis of Head and Neck Cancer (HNC) and ≥ 2 years from completion of&#xD;
             treatment for HNC, either clinically or radiologically No Evidence of Disease (NED),&#xD;
             as assessed by ENT or Radiation Oncologist within 28 days of study registration&#xD;
&#xD;
          -  Individuals at least 18 years of age and no older than 90 years of age&#xD;
&#xD;
          -  Xerostomia defined as less than or equal to 80 percent of baseline (pre-radiation)&#xD;
             salivary function per patient estimate&#xD;
&#xD;
          -  Karnofsky performance status ≥ 70, patient eligible for bone marrow aspirate with&#xD;
             wakeful anesthesia&#xD;
&#xD;
          -  Radiographically confirmed bilateral submandibular glands&#xD;
&#xD;
          -  Females of childbearing potential must agree to have a negative urine or serum&#xD;
             pregnancy test within 7 days prior to bone marrow biopsy. A female of child-bearing&#xD;
             potential is any woman (regardless of sexual orientation, having undergone a tubal&#xD;
             ligation, or remaining celibate by choice) who meets the following criteria:&#xD;
&#xD;
               -  has not undergone a hysterectomy or bilateral oophorectomy; or&#xD;
&#xD;
               -  has not been naturally postmenopausal for at least 12 consecutive months (i.e.,&#xD;
                  has had menses at any time in the preceding 12 consecutive months)&#xD;
&#xD;
          -  Women of childbearing potential in sexual relationships with men must have used an&#xD;
             acceptable method of contraception for 30 days prior to study registration and agree&#xD;
             to use an acceptable method of contraception until 4 weeks after completing study&#xD;
             treatment. Males must agree to avoid impregnation of women during and for four weeks&#xD;
             after completing study treatment through use of an acceptable method of contraception.&#xD;
&#xD;
        Note: Acceptable method of contraception includes, but is not limited to, barrier with&#xD;
        additional spermicidal foam or jelly, intrauterine device, hormonal contraception (started&#xD;
        at least 30 days prior to study enrollment), intercourse with men who underwent vasectomy)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of sialolithiasis&#xD;
&#xD;
          -  Patients with one submandibular gland&#xD;
&#xD;
          -  History of autoimmune diseases affecting salivary glands, including Sjögren's&#xD;
             syndrome, lupus, scleroderma, type I diabetes, sarcoidosis, and amyloidosis&#xD;
&#xD;
          -  Chronic graft vs host disease&#xD;
&#xD;
          -  Untreated oral candidiasis&#xD;
&#xD;
          -  Use of anti-cholinergic medications (e.g. atropine, ipratropium, oxybutynin,&#xD;
             scopolamine, solifenacin, tiotropium, etc…) while enrolled on study&#xD;
&#xD;
          -  Malignancy within the past 2 years, except adequately treated stage I lung cancer, low&#xD;
             risk prostate cancer that has been treated or is undergoing active surveillance,&#xD;
             adequately treated non-melanoma skin cancer, adequately treated ductal carcinoma in&#xD;
             situ (DCIS), or adequately treated stage I cervical cancer&#xD;
&#xD;
          -  Expected life expectancy ≤ 6 months&#xD;
&#xD;
          -  Lidocaine allergy&#xD;
&#xD;
          -  Use of investigational drugs, biologics, or devices within 30 days prior to enrollment&#xD;
&#xD;
          -  Women who are pregnant, lactating or planning on becoming pregnant during the study&#xD;
&#xD;
          -  Not suitable for study participation due to other reasons at the discretion of the&#xD;
             investigators&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Randall J Kimple, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jacques Galipeau, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Wisconsin</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>July 13, 2023</last_update_submitted>
  <last_update_submitted_qc>July 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</mesh_term>
    <mesh_term>Xerostomia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Interferons</mesh_term>
    <mesh_term>Interferon-gamma</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 9, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/32/NCT04489732/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04489732
org study id: 2020-1290
secondary id: A533300
secondary id: SMPH/HUMAN ONCOLOGY/HUMAN ONCO
secondary id: UW20025
secondary id: NCI-2021-00070
secondary id: 1UG3DE030431-01
secondary id: Protocol Version 10/7/2021
secondary id: Head & Neck SPORE
nct id: NCT04489732
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a single center pilot study designed to determine the safety and tolerability of
      autologous bone marrow-derived Mesenchymal Stromal Cells (MSCs) in patients with xerostomia
      (dry mouth) after undergoing radiation therapy (XRT) for head and neck cancer (HNC). Up to 12
      participants will be enrolled and can expect to be on study for up to 2 years.
Following the completion of screening/baseline procedures, and written consent, eligible
      participants will undergo bone marrow aspirate in order to obtain MSCs.

      The MSC Investigational Medicinal Product (IMP) (dose level 0, n=6, staggered) will be
      injected into one submandibular gland under local anesthesia, in the gland that received the
      lowest radiation dose. Patients with only one submandibular gland will be ineligible.

      All participants will be called by a study coordinator 3 days (+/- 2 days) after injection to
      assess pain and will have a phone visit with a physician 1 week (+/- 2 days) after injection
      during which the investigator will assess pain and ask about the area of injection regarding
      redness and/or swelling. All participants will complete a pain diary with daily entries over
      the first month to record the occurrence and severity of pain using a 0-10 visual analog
      scale and occurrence and severity of other adverse events (e.g., redness, swelling, warmth,
      tenderness, rash, pruritis, nausea, vomiting, fatigue). Participants will also keep a log of
      all pain medications taken including both narcotic and non-narcotic medications (e.g.
      ibuprofen, acetaminophen, etc.) for the first month. Participants will complete 5 follow-up
      visits over the course of 24 months - at 1, 3, 6, 12, and 24 months following the
      intervention. Salivary collection for analysis as well as QoL surveys will be obtained at
      these visits.

      Dose Reduction:

        -  If dose limiting toxicity (DLT) in less than or equal to 1 participant (n=6
           participants, staggered at least 14 days), Dose Level 0 will be recommended as starting
           dose for subsequent trial.

        -  If DLT in greater than 1 participant, dose level -1 will be administered, staggered at
           least 14 days in n=6 participants.

        -  If DLT in this cohort is in less than or equal to 1 participant, Dose Level -1 will be
           recommended as starting dose for subsequent trial. If DLT in greater than or equal to 2
           participants, study will be stopped.

      Primary Objective

        -  To evaluate the safety and tolerability of MSCs for subjects with xerostomia after
           radiation therapy for HNC.

      Secondary Objectives

        -  To evaluate the efficacy of MSCs for treatment of xerostomia and salivary hypofunction
           via quality-of-life (QoL) questionnaires, salivary amount, and salivary compositional
           analysis.

        -  To assess the imaging characteristics in HNC patients after MSC injection using
           ultrasound.

        -  To assess the feasibility of a future Phase 1 dose-escalation study.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: single-center, open-label, non-randomized, non-placebo controlled, single-group assignment, pilot study
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of subjects experiencing dose limiting toxicity (DLT)
time frame: up to 1 month post injection (up to 3 months from consent)
description: Dose limiting toxicity is defined as: submandibular pain > 5 on a standard 10-point pain scale of 0-10 at 1-month after MSC injection OR any serious AE OR any of the selected toxicities listed per protocol within one-month post-injection.
measure: Change in Saliva production rate
time frame: baseline (up to 8 weeks before injection), 1, 3, 6, 12, and 24 months post-injection
description: Whole saliva production rates will be measured under unstimulated and stimulated saliva collection conditions.
measure: Saliva composition analysis: Change in salivary pH
time frame: baseline (up to 8 weeks before injection), 1, 3, 6, 12, and 24 months post-injection
description: Salivary pH will be measured using a pH meter. The normal range of saliva pH is 6.2-7.6 .
measure: Saliva composition analysis: Change in total protein concentration in saliva
time frame: baseline (up to 8 weeks before injection), 1, 3, 6, 12, and 24 months post-injection
description: ELISA will be used to quantify total protein concentration in saliva. The normal range of total protein in saliva is 2-5 mg/mL.
measure: Saliva composition analysis: Change in amylase concentration in saliva
time frame: baseline (up to 8 weeks before injection), 1, 3, 6, 12, and 24 months post-injection
description: The enzyme-linked immunosorbent assay (ELISA) will be used to quantify amylase concentration in saliva. The normal range of amylase concentration in saliva is 10-150 U/mL.
measure: Saliva composition analysis: Change in mucin concentration in saliva
time frame: baseline (up to 8 weeks before injection), 1, 3, 6, 12, and 24 months post-injection
description: ELISA will be used to quantify mucin concentration in saliva.The normal range of mucin concentration in saliva is 1,000-3,000 ug/mL.
measure: Change in The University of Michigan Xerostomia Related Quality of Life (XeQOL) score
time frame: baseline (up to 8 weeks before injection), 1, 3, 6, 12, and 24 months post-injection
description: The University of Michigan Xerostomia Related Quality of Life (XeQOL) scale is a validated patient-reported assessment 15 item scale with 4 domains: physical functioning, pain/discomfort, personal/psychologic functioning, and social functioning. Participants will answer the questions on a scale of 1-5 (not a all, a little, somewhat, quite a bit, very much) for every item. Higher scores represent greater degree of symptoms.
measure: Change in The MD Anderson Dysphagia Index (MDADI) score
time frame: baseline(up to 8 weeks before injection), 1, 3, 6, 12, and 24 months post-injection
description: The MDADI is a 20-item questionnaire designed for evaluating the impact of dysphagia on the quality of life of patients with head and neck cancer. The MDADI score ranges from 20-100 with a lower scale representing worse dysphagia.
measure: Change in Visual Analogue Scale (VAS) xerostomia score
time frame: baseline (up to 8 weeks before injection), 1, 3, 6, 12, and 24 months post-injection
description: A Visual Analogue Scale questionnaire for subjective assessment of salivary dysfunction. The VAS xerostomia questionnaire is an 8-item questionnaire that provides a validated measure of the perception of dry mouth. Participants will be asked to mark their responses to each item by placing a vertical line on the 100-mm horizontal scale. The VAS ranges from 8-80 with a lower scale representing less dysphagia/symptoms
measure: Change in salivary gland size
time frame: baseline (up to 8 weeks before injection), 3, 6, and 12 months post-injection
description: Salivary gland size measured by ultrasound imaging
measure: Change in salivary gland stiffness measured by shear wave velocity
time frame: baseline (up to 8 weeks before injection), 3, 6, and 12 months post-injection
description: Salivary gland stiffness (fibrosis) will be measured by acoustic radiation force impulse imaging. Evaluators will be blinded to the time point of evaluation (pre- or post- MSC injection)
measure: Participant Drop out Rate
time frame: up to 24 months post-injection (up to 26 months from consent)
description: Study feasibility will in part be measured by participant drop out rate.
arm group label: Treatment with MSCs
arm group type: Experimental
description: A single dose of MSCs injected into the submandibular glands of patients with radiation-induced xerostomia
intervention type: Biological
intervention name: Autologous bone-marrow derived, interferon gamma stimulated mesenchymal stromal cells
description: Single dose, starting at
Dose Level 0: 10 x 10^6 injected into one submandibular gland on Day 1
arm group label: Treatment with MSCs
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Randall J Kimple, MD,PhD
role: Principal Investigator
affiliation: University of Wisconsin, Madison
last name: Jacques Galipeau, MD
role: Study Director
affiliation: University of Wisconsin, Madison
facility: 
country: United States
responsible party type: Sponsor
mesh term: Head and Neck Neoplasms
mesh term: Xerostomia
mesh term: Interferons
mesh term: Interferon-gamma
sharing ipd: No
provided document: 