Actively Recruiting
Dose-Escalation Trial of Mesenchymal Stromal Cells for Medical Xerostomia with Inflammatory Causes
Led by University of Wisconsin, Madison · Updated on 2026-02-10
36
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying the safety and tolerability of injecting mesenchymal stromal cells (MSCs) produced from bone marrow into the salivary glands of adults who experience dry mouth, especially when caused by inflammatory conditions like Sjogren's disease or graft-versus-host disease. This phase I, open-label trial focuses on whether these injections can improve symptoms of dry mouth without causing significant side effects. Participants will first have bone marrow collected through a needle procedure to obtain MSCs. Then, they will receive injections of these cells into one or both submandibular salivary glands under local anesthesia. The study includes a dose-escalation design where an initial group receives MSCs injected into one gland, followed by larger groups receiving injections into both glands at increasing doses to identify the highest tolerable dose. After this, an expansion cohort will receive the recommended phase II dose. During the trial, participants will undergo ultrasound imaging of their salivary glands and complete questionnaires about their dry mouth symptoms. Researchers will monitor safety by tracking any serious side effects or pain after injections, mainly within the first month. They will also measure changes in dry mouth severity and saliva production over two years. The total study duration includes screening, treatment, and long-term follow-up to assess both safety and potential improvements in salivary function.
CONDITIONS
Brief Title
Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Medical Xerostomia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Xerostomia with unstimulated salivary flow less than 1.2 mL in 5 minutes documented after diagnosis and before enrollment
- Xerostomia not caused by radiotherapy (medical xerostomia)
- Age between 18 and 90 years
- Karnofsky performance status of 70 or higher and eligible for bone marrow aspiration under local anesthesia
- Ability and willingness to give informed consent
- Radiographic confirmation of bilateral submandibular glands
- Negative pregnancy test if female of childbearing potential
- Males and females of childbearing potential willing to use acceptable contraception
- Laboratory values within 28 days before enrollment: hemoglobin 9 g/dL or higher, platelets 100,000/µL or higher, ANC 1000/µL or higher, lymphocytes 800/µL or higher, and normal PT/INR and PTT based on age and sex
You will not qualify if you...
- Having only one submandibular gland
- Presence of sialolithiasis (salivary gland stones)
- Poorly controlled diabetes mellitus (HbA1c 7% or higher)
- Use of diuretic therapy started before dry mouth symptoms and still ongoing if symptoms are believed to be caused by diuretics
- Untreated oral candidiasis at enrollment
- History of malignancy within the last 2 years except certain treated low-risk cancers
- Unstable immunosuppressive therapy within the last 2 months
- Requirement for transfusions
- Life expectancy of 6 months or less as judged by the investigator
- Use of investigational drugs, biologics, or devices within 30 days before enrollment
- Pregnant or breastfeeding women or those planning pregnancy during the study
- Other reasons making participation unsuitable as determined by investigators
- Enrollment in another clinical study that may interfere with this trial's endpoints
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 1 day
Participants undergo bone marrow aspiration to obtain mesenchymal stromal cells (MSCs) for treatment.
1 interventional visit (in-person)
Duration - Single treatment visit with follow-up over 1 month for safety monitoring
Participants receive injections of MSCs into one or both submandibular glands under local anesthesia as per dose escalation or expansion cohorts.
1 treatment visit and multiple follow-up visits over 1 month
Duration - Up to 24 months
Participants are monitored for safety, xerostomia symptoms, and salivary function for up to 24 months after treatment.
Visits at 1 month, 3 months, 6 months, 12 months, and 24 months post-treatment
Trial Site Locations
Total: 1 location
1
University of Wisconsin
Madison, Wisconsin, United States, 53705
Actively Recruiting
Research Team
C
Cancer Connect
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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