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Bone marrow cells injected into salivary glands to fight dry mouth

NCT ID NCT06392711

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Nov 2028

An estimate. End dates often move.

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

18 to 90 years

Sex

Anyone

Healthy volunteers

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

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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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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • University of Wisconsin

    RECRUITING

    Madison, Wisconsin, 53705, United States

    Contact Email: •••••@•••••

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