Safety and Tolerability Study of Allogeneic Mesenchymal Stem Cell Infusion in Adults With Cystic Fibrosis

Cystic Fibrosis (CF) Subject Inclusion Criteria:

• Male or female ≥18 years of age
• Confirmed diagnosis of CF as evidenced by 1 or more clinical features consistent with the CF phenotype and 1 or more of the following criteria:
• Sweat chloride equal to or greater than 60 milliequivalents per liter (mEq/L) by quantitative pilocarpine iontophoresis test (QPIT)
• 2 well-characterized, disease causing mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
• Clinically stable with no significant changes in health status within 2 weeks prior to screening.
• Forced expiratory volume in the first second (FEV1) ≥ 40% predicted for age based on the global lung function initiative equations at the screening visit
• Weight ≥ 40 kilograms at the screening visit
• Able to perform repeatable, consistent efforts in pulmonary function testing
• Written informed consent obtained from the subject.

CF Subject Exclusion Criteria:

• Use of an investigational agent within the 4-week period prior to Visit 1 (Day -42 to -10)
• Chronic daily (>10 mg) or alternate daily (>20 mg on alternate days) use of systemic corticosteroids within the 4 weeks prior to Visit 1 (Day -42 to -10) or initiation of any dosage of systemic corticosteroids within 72 hours prior to Visit 2 (Day 1).
• Use of hydroxychloroquine or immunosuppressants.
• Initiation of a new antibiotic (oral, intravenous, and/or inhaled) that is not part of the subject's maintenance regimen for treatment of acute respiratory symptoms within 2 weeks prior to screening through Visit 2 (Day 1)
• Initiation of any new chronic therapy (e.g., Pulmozyme®, hypertonic saline, Kalydeco®, Orkambi®, high-dose ibuprofen azithromycin, TOBI®, Cayston®, nebulized colistiin, bronchodilators, inhaled corticosteroids, etc.) within 4 weeks prior to screening
• Active treatment for non-tuberculous Mycobacteria
• History of a sputum culture positive for a Burkholderia cepacia complex organism in the previous 12 months.
• Current tobacco smoker
• Oxygen saturation 2.5 times the upper limit of normal at screening, documented biliary cirrhosis, or portal hypertension
• Total bilirubin concentration > 1.2 milligram per deciliter (mg/dL) at screening
• Creatinine > 1.8 mg/dL at screening
• Pregnant, breastfeeding, or unwilling to practice birth control between Visit 2 (Day 1) and Telephone Call 3 (Day 56) (acceptable forms of contraception: abstinence, hormonal birth control, intrauterine device, or barrier method plus a spermicidal agent), unless surgically sterilized or postmenopausal
• Screening hematology with white blood cell count < 4.5 x 109 cells/liter, hematocrit < 30%, and platelets < 150 x 109 platelets/liter
• History of invasive cancer requiring systemic therapy
• History of organ transplantation
• Currently listed for lung transplantation or having potential to be listed for lung transplantation in the succeeding 12 calendar months from screening
• Subject unlikely to complete the study as determined by the Investigator

Inclusion Criteria for Healthy Volunteer Donors (NOTE: Enrollment for Healthy Volunteers is closed):

• Male/female age ≥ 18 years to ≤ 40 years
• Able to understand and sign consent form (a legally authorized representative will not be permitted)

Inclusion Criteria for CF Donors:

• CF subject enrolled in the main study and consented to this optional procedure

Exclusion Criteria for both Healthy Volunteer (HV) Donors and CF Donors:

• Fever or current illness on the day of the cell collection
• Evidence of communicable disease
• Any significant change in health status within 2 weeks prior to cell collection that the Principal Investigator/Sub-Investigator deems relevant to exclude participation
• Subject reported history of organ transplantation
• Subject reported history of human immunodeficiency virus, hepatitis B or C, or syphilis
• For HV donors only, subject-reported known history of being diagnosed with cystic