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

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.

Conditions

Head and Neck Cancer, Xerostomia

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Head and Neck Cancer
Intervention / Treatment

-

Contacts and Locations

Madison

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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)
  • * Xerostomia, defined as patient reported salivary function (pre-treatment) ≤ 80% of healthy (pre-radiation)
  • * ≥ 18 years of age, ≤ 90 years of age.
  • * Patients ≥ 2 years from completion of radiation therapy for HNC
  • * Karnofsky performance status ≥ 70, patient eligible for bone marrow aspirate with wakeful anesthesia
  • * Willing and able to give informed consent
  • * Radiographically confirmed submandibular gland(s)
  • * Salivary gland disease (i.e., sialolithiasis)

Ages Eligible for Study

18 Years to 90 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2026-03-31