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Study Transplanting Bone Marrow Cells Into Salivary Glands to Treat Dry Mouth Caused by Radiation Therapy | Clinical Trials | Clareo Health

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

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

NCT05820711•University of Wisconsin, Madison

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 90 years

Sex

ALL

Healthy Volunteers

Inclusion 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)

Exclusion Criteria

•Salivary gland disease (i.e., sialolithiasis)

Locations (1)

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Key Dates

Start Date

July 17, 2023

Primary Completion Date

December 9, 2025

Completion Date

January 1, 2028

Last Updated

February 9, 2026

Enrollment

ACTUAL participants

Conditions

Head and Neck CancerXerostomia

Interventions

MSC

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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