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

Inclusion Criteria:

• Xerostomia, defined as an unstimulated salivary flow of less than or equal to 0.5 mLin 5 minutes

• Xerostomia not resulting from radiotherapy (medical xerostomia) defined as anunstimulated salivary flow ≤0.5 mL/5 minutes documented at any time followingXerostomia diagnosis and prior to enrollment.

• ≥ 18 years of age, ≤ 90 years of age

• Karnofsky performance status ≥ 70, patient eligible for bone marrow aspirate withwakeful 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 42 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 orESRD

• 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 adequatelytreated stage I cervical cancer)

• For patients on immunosuppressive therapy, must be on stable dose ofimmunosuppressive therapy for at least 2 months, allowing for dose adjustments forblood 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 toenrollment

• 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 ofinvestigators.

• Enrollment in another clinical study possibly interfering with the endpoints of thisstudy