ACTIVE_NOT_RECRUITING

Study Transplanting Bone Marrow Cells Into Salivary Glands to Treat Dry Mouth Caused by Radiation Therapy

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Conditions

Head and Neck CancerXerostomia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical research study is to evaluate the safety and tolerability of injecting certain cells that you produce in your bone marrow called mesenchymal stem cells (MSCs) into your salivary glands. Participants will have head and neck cancer that was treated with radiation therapy, and in this study will: * Undergo a collection of bone marrow using a needle; * Donate saliva; * Undergo a salivary gland ultrasound; and, * Complete questionnaires that ask about dry mouth Participants can expect to be in this study for up to 30 months. There is no expanded access program available per this protocol.

Official Title

A Phase I Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Xerostomia After Radiation Therapy for Head and Neck Cancer

Quick Facts

Study Start:2023-07-17
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05820711

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * History of histological diagnosis of head and neck cancer (HNC) that was treated with radiation therapy and currently clinically or radiologically no evidence of disease (NED)
  2. * Xerostomia, defined as patient reported salivary function (pre-treatment) ≤ 80% of healthy (pre-radiation)
  3. * ≥ 18 years of age, ≤ 90 years of age.
  4. * Patients ≥ 2 years from completion of radiation therapy for HNC
  5. * Karnofsky performance status ≥ 70, patient eligible for bone marrow aspirate with wakeful anesthesia
  6. * Willing and able to give informed consent
  7. * Radiographically confirmed submandibular gland(s)
  1. * Salivary gland disease (i.e., sialolithiasis)

Contacts and Locations

Principal Investigator

Randall Kimple, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Jacques Galipeau, MD
STUDY_DIRECTOR
University of Wisconsin, Madison

Study Locations (Sites)

University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53705
United States

Collaborators and Investigators

Sponsor: University of Wisconsin, Madison

  • Randall Kimple, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Wisconsin, Madison
  • Jacques Galipeau, MD, STUDY_DIRECTOR, University of Wisconsin, Madison

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-17
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2023-07-17
Study Completion Date2026-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Head and Neck Cancer
  • Xerostomia