Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Osteoarthritic Pain

Exclusion Criteria

• •1. 1\. Hypersensitivity, allergy, or significant reaction to any ingredient of the study drug, including double-stranded DNA, mannose, and sucrose
• •2. Subject plans knee arthroplasty within 4 months, irrespective of the outcome of the trial or other conservative therapies
• •3. High peri-procedural risks which in the judgment of the investigator preclude a safe knee injection procedure (e.g., poorly controlled diabetes, cardiac inadequacy such as NYHA class \> II, G4 glomerular filtration rate \[eGFR \< 30 mL/min by Cockcroft-Gault\])
• •4. Current treatment with immunosuppressives (steroid therapy equivalent to \>10mg/day prednisone); or other strong immunosuppressant
• •5. History of systemic immunosuppressive therapy; steroids (equivalent to \>10mg/day prednisone) in the last 3 months
• •6. Currently receiving systemic chemotherapy or radiation therapy for malignancy
• •7. 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)
• •8. Severe anemia (Grade 3; hemoglobin \<8.0 g/dL, \<4.9 mmol/L, \<80 g/L; transfusion indicated), uncontrolled coagulopathy (Grade 1, prolonged activated partial prothrombin time (aPTT) \> upper limit of normal (ULN) to 1.5xULN), or bleeding diathesis, Grade 1 white cell counts (lymphocytes \<LLN - 800/mm3; \<LLN - 0.8 x 10e9 /L, neutrophils \<LLN - 1500/mm3; \<LLN - 1.5 x 10e9 /L)
• •9. Positive serology for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus within 4 weeks of commencing the study
• •10. Significant neuropsychiatric conditions; dementia, major depression, or altered mental state that in the opinion of the Investigator will interfere with study participation
• •11. Current treatment with systemic antibiotics or antivirals (EXCEPTION: topical treatments)
• •12. Current treatment with anticoagulants, other than low-dose aspirin, prescribed for new onset of symptoms in 3 months before screening visit.
• •13. Known or suspected history of active alcohol or intravenous/oral drug abuse within 1 year before the screening visit
• •14. Women who are pregnant or nursing
• •15. 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.
• •16. Any condition that, in the opinion of the Principal Investigator, could compromise the safety of the subject, the subject's ability to communicate with the study staff, or the quality of the data