Bone marrow cells injected into salivary glands to fight dry mouth
NCT ID NCT06392711
First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 2 times
Summary
This early-phase trial tests whether injecting mesenchymal stromal cells (MSCs) into the salivary glands is safe and can ease dry mouth in people with graft-versus-host disease or Sjogren's disease. Up to 36 adults will receive one injection and be monitored for pain and side effects. The study is primarily checking safety, but will also track changes in dry mouth symptoms.
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 (MSCs)
- What this could lead to
- If it works, this could point toward a new way to treat chronic dry mouth without radiation.
- What could go wrong
- This is a very early, small phase 1 trial focused on safety, not proof of effectiveness. The approach may not improve symptoms and could cause pain or other side effects.
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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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Nov 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.
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: * Xerostomia, defined as an unstimulated salivary flow \<1.2 mL in 5 minutes documented at any time following xerostomia diagnosis and prior to enrollment * Xerostomia not resulting from radiotherapy (medical xerostomia) * ≥ 18 years of age, ≤ 90 years of age * Karnofsky performance status ≥ 70, patient eligible for bone marrow aspirate with wakeful anesthesia * Willing and able to give informed consent * Radiographically confirmed bilateral submandibular glands * If female of childbearing potential, negative pregnancy test * Males and females of childbearing potential willing to use acceptable contraception * Laboratory Values (within 28 calendar days of enrollment): * Hgb ≥ 9 g/dL (5.58 mmol/L) * Platelets ≥ 100,000/µL * ANC ≥ 1000/µL * Lymphocytes ≥ 800/µL * PT/INR and PTT within normal limits based on age/sex Exclusion Criteria: * Patients with one submandibular gland * Sialolithiasis * Poorly-controlled diabetes mellitus (HbA1c ≥ 7%) * Patients who initiated any diuretic therapy before developing dry mouth symptoms and are still on diuretic therapy and the referring provider believes the dryness symptoms are driven by diuretic use * Untreated oral candidiasis based on physical exam at enrollment * Malignancy within the last 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 DCIS, or adequately treated stage I cervical cancer) * For patients on immunosuppressive therapy, must be on stable dose of immunosuppressive therapy for at least 2 months, allowing for dose adjustments for blood levels of drugs * Transfusion dependency * Life expectancy ≤ 6 months as determined by the investigator * Use of investigational drugs, biologics, or devices within 30 calendar days prior to enrollment * Pregnant or lactating women or those who plan to become pregnant during the study * Not suitable for study participation due to other reasons at discretion of investigators. * Enrollment in another clinical study possibly interfering with the endpoints of this study
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Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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University of Wisconsin
RECRUITINGMadison, Wisconsin, 53705, United States
Contact Email: •••••@•••••
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- Can steroid shots shield salivary glands from radiation damage?
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