Actively Recruiting
Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Medical Xerostomia
Led by University of Wisconsin, Madison · Updated on 2026-02-10
36
Participants Needed
1
Research Sites
212 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. Participants will: * have bone marrow collected using a needle * undergo a salivary gland ultrasound * complete questionnaires * receive an injection of the bone marrow cells into a salivary gland
CONDITIONS
Official Title
Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Medical Xerostomia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Xerostomia defined as unstimulated salivary flow less than 1.2 mL in 5 minutes documented after xerostomia diagnosis and before enrollment
- Xerostomia not caused by radiotherapy (medical xerostomia)
- Age between 18 and 90 years
- Karnofsky performance status of 70 or higher, eligible for bone marrow aspirate with wakeful anesthesia
- Able and willing to provide informed consent
- Bilateral submandibular glands confirmed by imaging
- Negative pregnancy test for females of childbearing potential
- Males and females of childbearing potential willing to use acceptable contraception
- Laboratory values within 28 days prior to enrollment: hemoglobin at least 9 g/dL, platelets at least 100,000/μL, ANC at least 1000/μL, lymphocytes at least 800/μL, and PT/INR and PTT within normal limits based on age and sex
You will not qualify if you...
- Having only one submandibular gland
- Presence of sialolithiasis
- Poorly-controlled diabetes mellitus with HbA1c 7% or higher
- Ongoing diuretic therapy initiated before dry mouth symptoms if provider believes diuretics cause dryness
- Untreated oral candidiasis at enrollment
- Malignancy within the past 2 years except specific adequately treated cancers
- Unstable immunosuppressive therapy dose within the last 2 months
- Transfusion dependency
- Life expectancy 6 months or less
- Use of investigational drugs, biologics, or devices within 30 days before enrollment
- Pregnant or lactating women or those planning pregnancy during the study
- Unsuitability for study participation as determined by investigators
- Participation in another clinical study that may interfere with this study's endpoints
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Wisconsin
Madison, Wisconsin, United States, 53705
Actively Recruiting
Research Team
C
Cancer Connect
CONTACT
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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