Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Medical Xerostomia
Recruiting · NCT06392711 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Wisconsin, Madison
View the official record on ClinicalTrials.gov →Interventions studied
Mesenchymal Stromal Cells (MSC) Dose Level 0Mesenchymal Stromal Cells (MSC) Dose Level 1
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
Who can take part
Age range
18 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed across 1 US state.
- University of Wisconsin - Madison, Wisconsin, United States