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

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 ade…