Safety and Efficacy of XT-150 for Facet Joint Osteoarthritis Pain

Exclusion Criteria

• •1. Hypersensitivity, allergy, or significant reaction to lidocaine or any ingredient of the study drug, including double-stranded DNA, mannose, and sucrose
• •2. Facet injection with corticosteroid in the past 6 months
• •3. Lumbar medial branch nerve ablation (e.g., by radiofrequency technique) within the past 12 months
• •4. Prior lumbar fusion surgery
• •5. Prior or existing medial branch nerve stimulation device (e.g., Mainstay device)
• •6. Scheduled surgical procedure or nerve ablation to joint within the next 6 months; participant agrees not to schedule a surgical procedure, nerve ablation, or added facet injection within 6 months of study treatment
• •7. High peri-operative risks which in the judgment of the investigator preclude a safe facet joint injection procedure (e.g. extreme obesity putting injection accuracy at risk, etc.)
• •8. Current treatment with immunosuppressive (systemic corticosteroid therapy \[equivalent to \>10 milligrams per day {mg/day} prednisone\] or other strong immunosuppressant)
• •9. History of immunosuppressive therapy; high-potency systemic steroids in the last 3 months.
• •10. Currently receiving systemic chemotherapy or radiation therapy for malignancy
• •11. Clinically significant hepatic disease as indicated by clinical laboratory results ≥3 times the upper limit of normal for any liver function test (e.g., aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase)
• •12. Severe anemia (Grade 3; hemoglobin \<8.0 grams per deciliter \[g/dL\], \<4.9 millimoles per liter \[mmol/L\], \<80 g/L; transfusion indicated), Grade 1 white cell counts (lymphocytes \<Lower limit of normal \[LLN\] - 800/cubic millimeters \[mm\^3\]; \<LLN - 0.8 x 10\^9/L, neutrophils \<LLN - 1500/mm\^3; \<LLN - 1.5 x 10\^9/L)
• •13. Positive serology with reflex for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus within 4 weeks of commencing the study
• •14. Significant neuropsychiatric conditions, dementia, major depression, or altered mental state that in the opinion of the Investigator will interfere with study participation
• •15. Current treatment with systemic antibiotics or antivirals (EXCEPTION: topical treatments)
• •16. Current treatment with anticoagulants, other than low-dose aspirin. Participants, if medically feasible, can interrupt anticoagulant therapy by following local medical practice protocol for intra-articular injections for participants on anticoagulant, antiplatelet therapy.
• •17. Known or suspected history of active alcohol or intravenous/oral drug abuse within 1 year before the screening visit
• •18. Use of any investigational drug or device within 1 month before enrollment or current participation in a trial that included intervention with a drug or device; or currently participating in an investigational drug or device study.
• •19. Any condition that, in the opinion of the Principal Investigator, could compromise the safety of the participant, the participant's ability to communicate with the study staff, or the quality of the data