Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Medical Xerostomia
Key facts
- Where
- Madison, United StatesSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 90 years old?
Source: NCT06392711, who can take part
Where in United States
- University of WisconsinMadison, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Wisconsin, Madison
- Trial code
- NCT06392711
- Record updated
- 19 August 2026
- Original 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.Read full original descriptionShow less
UW23129: A Phase I Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Medical Xerostomia
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
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 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; 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; Use of investigational drugs, biologics, or devices within 30 calendar days prior to 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); Poorly-controlled diabetes mellitus (HbA1c ≥ 7%); Patients with one submandibular gland; Sialolithiasis; Untreated oral candidiasis based on physical exam at enrollment; Transfusion dependency; Life expectancy ≤ 6 months as determined by the investigator; 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.