Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Medical Xerostomia

Prior treatment

• 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

Other illness

• 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)

Lab values

• Poorly-controlled diabetes mellitus (HbA1c ≥ 7%)

Other

• 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

• 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