Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Medical Xerostomia
UW23129: A Phase I Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Medical Xerostomia
University of Wisconsin, Madison
36 participants
Oct 4, 2024
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Inclusion Criteria14
- 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 Criteria13
- 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
Interventions
10 (8-12) x 10\^6 MSCs
20 (16-24) x 10\^6
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06392711