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
• Xerostomia, defined as an unstimulated salivary flow of less than or equal to 0.5 mL in 5 minutes
• Xerostomia not resulting from radiotherapy (medical xerostomia) defined as an unstimulated salivary flow ≤0.5 mL/5 minutes documented at any time following Xerostomia diagnosis and prior to enrollment.
• ≥ 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