Stem cells aim to quench Radiation-Induced dry mouth in cancer survivors
NCT ID NCT05820711
First seen Jun 27, 2026 · Last updated Jul 22, 2026 · Updated 2 times
Summary
This early-phase study tests whether injecting a person's own bone marrow stem cells into their salivary glands is safe and tolerable for treating dry mouth caused by radiation therapy for head and neck cancer. About 23 participants who finished radiation at least 2 years ago will undergo a bone marrow collection, receive the cell injection, and be followed for up to 30 months. The main goal is to find the safest dose and watch for side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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23 people
The number who actually took part.
- Started
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Jul 2023
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53705, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Experimental pill HG146 put to the test against rare head and neck cancer
- Can a dental assistant keep cancer Patients' mouths healthier during radiation?
- Why do Non-Smokers get head and neck cancer? scientists probe tumor DNA
- Re-irradiation plus cetuximab targets head and neck tumors that return
- Sharper tumor maps: PET scans could tighten radiation beams
- Could popular Weight-Loss drugs quietly reshape your mouth?