Back to search results

Mesenchymal Stromal Cells for Medical Xerostomia

This study is testing the safety and how well Mesenchymal Stromal Cells (MSCs) work to treat medical xerostomia (dry mouth). MSCs are special cells from your bone marrow. This trial is for people aged 18 to 90 who have dry mouth not caused by radiation, including those with Sjogren's Disease or graft-versus-host disease. The main goal is to see if injecting MSCs into your salivary glands is safe and helps improve dry mouth. The study is currently unclear on its recruitment status and plans to enroll 36 participants.

Study design
This is an open-label, non-randomized study that will test different doses of MSCs in a single group of participants. It will start with a small group and then expand to include more participants.
What's involved
You would have bone marrow collected, undergo a salivary gland ultrasound, complete questionnaires, and receive an injection of the bone marrow cells into a salivary gland.
Compensation
Not stated in the trial record.
Follow-up
The primary safety endpoints are measured at 1 month post-injection.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06392711

Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Medical Xerostomia

Recruiting
PHASE1Ages 18–90InterventionalTreatment
University of Wisconsin, Madison
~36 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:Mesenchymal Stromal Cells (MSC) Dose Level 0Mesenchymal Stromal Cells (MSC) Dose Level 1

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants experiencing DLT of submandibular pain
Measured over 1 month post-injection
+2 more outcomes measured

Conditions

Xerostomia
Graft-versus-host-disease
Sjogren's Disease

Explore related trials

Graft Versus Host DiseaseSjogren SyndromeXerostomia

Where it's being run

1 sites across 1 states
Wisconsin1

Study leadership

  • Zhubin Gahvari, MD, MS · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison
  • Jacques Galipeau, MD · STUDY_DIRECTOR · University of Wisconsin, Madison

Who to contact

Cancer Connect
[email protected]
800-622-8922
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Proportion of participants experiencing DLT of submandibular pain1 month post-injection

    Recommended phase II dose (RP2D) will be determined by the proportion of subjects experiencing the dose-limiting toxicity (DLT) of submandibular pain \> 5 on a standard 10-point pain scale of 0-10 at 1-month after MSC injection

  • Proportion of participants experiencing DLT as serious adverse events (AEs)1 month post-injection

    RP2D will be determined by the proportion of subjects experiencing the dose-limiting toxicity (DLT) of any serious AE within one-month post-injection

  • Proportion of participants experiencing DLT as pre-specified toxicities1 month post-injection

    RP2D will be determined by the proportion of subjects experiencing the dose-limiting toxicity (DLT) of any selected toxicity that is specified in the protocol within one-month post-injection