NCT06392711 · University of Wisconsin, Madison
Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Medical Xerostomia
What this study is about
The goal of this clinical trial is to evaluate the safety and how well patients handle the treatment of injecting certain cells produced in bone marrow called mesenchymal stromal cells (MSCs) into salivary glands. The main question it aims to answer is whether injection of MSCs into salivary glands results in any improvement in dry mouth.
View original scientific description
The goal of this clinical trial is to evaluate the safety and tolerability of injecting certain cells produced in bone marrow called mesenchymal stromal cells (MSCs) into salivary glands. The main question it aims to answer is whether injection of MSCs into salivary glands results in any improvement in dry mouth.
Interventions
BIOLOGICAL
Mesenchymal Stromal Cells (MSC) Dose Level 0
10 (8-12) x 10\^6 MSCs
BIOLOGICAL
Mesenchymal Stromal Cells (MSC) Dose Level 1
20 (16-24) x 10\^6
Primary outcome measures
Proportion of participants experiencing DLT of submandibular pain
Time frame: 1 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)
Time frame: 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 toxicities
Time frame: 1 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Madison, Wisconsin
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 22, 2026 · Source of record for eligibility and locations