Transplanting Bone Marrow Cells into Salivary Glands For Treating Patients with Medical Dry Mouth

Inclusion Criteria

• Physician diagnosis of SjD or GVHD
• Willing to provide informed consent
• Willing to comply with all study procedures and be available for the duration of the study
• Individuals at least 18 years of age and no older than 90 years of age
• Symptoms of xerostomia for six months or more
• Xerostomia not resulting from radiotherapy (medical xerostomia) defined as an unstimulated salivary flow =< 0.5 mL/5 minutes
• Karnofsky performance status >= 70, patient eligible for bone marrow aspirate with wakeful anesthesia as determined by the investigator
• Radiographically confirmed bilateral submandibular glands
• Females of childbearing potential must agree to have a negative urine or serum pregnancy test within 7 calendar days prior to bone marrow biopsy. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
• Women of childbearing potential in sexual relationships with men must have used an acceptable method of contraception for 30 calendar days prior to enrollment and agree to use an acceptable method of contraception until 4 weeks after completing study treatment. Males must agree to avoid impregnation of women during and for four weeks after completing study treatment through use of an acceptable method of contraception * Note: Includes, but is not limited to, barrier with additional spermicidal foam or jelly, intrauterine device, hormonal contraception (started at least 30 calendar days prior to study enrollment), intercourse with men who underwent vasectomy
• Hemoglobin (Hgb) >= 9 g/dL (5.58 mmol/L) (within 42 calendar days of enrollment)
• Platelets >= 50,000/uL (within 42 calendar days of enrollment)
• Absolute neutrophil count (ANC) >= 1000/uL (within 42 calendar days of enrollment)
• Lymphocytes >= 800/uL (within 42 calendar days of enrollment)
• Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) within normal limits based on age/sex (within 42 calendar days of enrollment)

Exclusion Criteria

• History of sialolithiasis
• Patients with one submandibular gland
• Poorly controlled diabetes (glycosylated hemoglobin A1c [HBA1c] >= 7%)
• End stage renal disease
• Untreated oral candidiasis based on physical exam at enrollment
• Patients who initiated any diuretic therapy before developing dry mouth symptoms
• Malignancy within the past 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 ductal carcinoma in situ (DCIS), or adequately treated stage I cervical cancer
• For patients on immunosuppressive therapy, they must be on a stable dose of immunosuppressive therapy for at least 2 months, allowing for dose adjustments to maintain blood levels of medications
• Expected life expectancy =< 6 months as determined by the investigator
• Use of investigational drugs, biologics, or devices within 30 calendar days prior to enrollment
• Women who are pregnant, lactating or planning on becoming pregnant during the study
• Not suitable for study participation due to other reasons at the discretion of the investigators
• Enrollment in another clinical study possibly interfering with the endpoints of this study
• Transfusion dependency to maintain safe blood counts