Stem cell shot aims to cure radiation dry mouth
NCT ID NCT04489732
First seen Jun 27, 2026 · Last updated Jul 21, 2026 · Updated 2 times
Summary
This early study tested whether injecting a patient's own stem cells into the saliva gland could safely help dry mouth caused by radiation therapy for head and neck cancer. Six participants received one injection, with a second offered later. The main goal was to check for side effects like pain or serious complications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mesenchymal stromal cells (stem cells from the patient's own bone marrow)
- What this could lead to
- If it works, this could point toward a treatment for chronic dry mouth after radiation therapy.
- What could go wrong
- This is a very early, small pilot study with only 6 participants, so results may not apply widely. The main risk is pain or serious side effects from the injection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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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6 people
The number who actually took part.
- Started
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Feb 2022
- Finished
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May 2026
- Lead sponsor
-
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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Willing to provide informed consent * Willing to comply with all study procedures and be available for the duration of the study * Histological diagnosis of Head and Neck Cancer (HNC) and ≥ 2 years from completion of treatment for HNC, either clinically or radiologically No Evidence of Disease (NED), as assessed by ENT or Radiation Oncologist within 28 days of study registration * Individuals at least 18 years of age and no older than 90 years of age * Xerostomia defined as less than or equal to 80 percent of baseline (pre-radiation) salivary function per patient estimate * Karnofsky performance status ≥ 70, patient eligible for bone marrow aspirate with wakeful anesthesia * Radiographically confirmed bilateral submandibular glands * Females of childbearing potential must agree to have a negative urine or serum pregnancy test within 7 days prior to bone marrow biopsy. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * has not undergone a hysterectomy or bilateral oophorectomy; or * has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months) * Women of childbearing potential in sexual relationships with men must have used an acceptable method of contraception for 30 days prior to study registration and agree to use an acceptable method of contraception until 4 weeks after completing study treatment. Males must agree to avoid impregnation of women during and for four weeks after completing study treatment through use of an acceptable method of contraception. Note: Acceptable method of contraception includes, but is not limited to, barrier with additional spermicidal foam or jelly, intrauterine device, hormonal contraception (started at least 30 days prior to study enrollment), intercourse with men who underwent vasectomy) Exclusion Criteria: * History of sialolithiasis * Patients with one submandibular gland * History of autoimmune diseases affecting salivary glands, including Sjögren's syndrome, lupus, scleroderma, type I diabetes, sarcoidosis, and amyloidosis * Chronic graft vs host disease * Untreated oral candidiasis * Use of anti-cholinergic medications (e.g. atropine, ipratropium, oxybutynin, scopolamine, solifenacin, tiotropium, etc…) while enrolled on study * Malignancy within the past 2 years, except adequately treated stage I lung cancer, low risk prostate cancer that has been treated or is undergoing active surveillance, adequately treated non-melanoma skin cancer, adequately treated ductal carcinoma in situ (DCIS), or adequately treated stage I cervical cancer * Expected life expectancy ≤ 6 months * Lidocaine allergy * Use of investigational drugs, biologics, or devices within 30 days prior to enrollment * Women who are pregnant, lactating or planning on becoming pregnant during the study * Not suitable for study participation due to other reasons at the discretion of the investigators
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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
Madison, Wisconsin, 53705, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a dental assistant keep cancer Patients' mouths healthier during radiation?
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- Re-irradiation plus cetuximab targets head and neck tumors that return
- Sharper tumor maps: PET scans could tighten radiation beams
- Five days of radiation instead of weeks: a new test for head and neck cancer