Phase II Study to Assess Safety and Efficacy of SL-1002 for Osteoarthritic Knee Pain

Exclusion Criteria

• •1\. Patients with evidence of inflammatory arthritis (e.g., rheumatoid arthritis) or any other systemic inflammatory condition (e.g., gout, pseudogout). 2. Current diagnosis of fibromyalgia. 3. Patients with evidence of neuropathic pain affecting the index knee. 4. Patients with prior or planned lower limb amputation. 5. Patients who have received an intra-articular steroid injection into the index knee within 90 days of study Screening Visit 1. 6. Patients who have received hyaluronic acid injection, Platelet Rich Plasma (PRP), stem cell or arthroscopic debridement/lavage injection into the index knee within 180 days of study Screening Visit
• •Patients who have received prior radiofrequency ablation or any other neurolytic procedure of the genicular nerves of the index knee within 1 year of study Screening Visit 1.
• •Patients who have received prior partial, resurfacing, or total knee arthroplasty of the index knee (residual hardware).
• •Patients with clinically significant ligamentous laxity of the index knee as per Investigator discretion.
• •Patients with clinically significant valgus/varus deformities or evidence of pathology (other than osteoarthritis of the knee) that materially affects gait or function of the index knee or is the underlying cause of the knee pain and/or functional limitations.
• •Patients who are extremely thin and those with minimal subcutaneous tissue thickness that could place the patient at risk of a chemical skin burn, at the discretion of the Investigator.
• •Patients with a pending or active compensation claim, litigation or disability remuneration (possibility of secondary gain).
• •Patients with chronic pain associated with significant psychosocial dysfunction.
• •Patients with a Patient Health Questionnaire - 9 (PHQ-9) score of \>10 (indicative of a state of moderate depression).
• •Patients with a systemic infection, active joint infection, or localized infection at the planned needle entry sites (patient may be considered for inclusion once infection is resolved).
• •Patients with history of uncontrolled coagulopathy or unexplained or uncontrollable bleeding that cannot be corrected, and patients with coagulopathy or who are being treated with anticoagulants.
• •Patients with moderate to severe hepatic impairment or moderate to severe renal impairment.
• •Identifiable anatomical variability that would materially alter the procedure as described in the protocol.
• •Patients currently prescribed opioid medications at a dose of \>50 daily morphine equivalents.
• •Patients with uncontrolled immunosuppression (e.g., AIDs, cancer, diabetes) as per Investigator discretion.
• •Female patients who are pregnant or planning to become pregnant during the duration of the study.
• •Female patients who are breast-feeding.
• •Patients who are unable or unwilling to comply with the requirements of the protocol.
• •Patients taking any of the following concurrent medications/over-the counter products (refer to Appendix 8 in full protocol for a list of applicable medications): c. Probenecid or other organic anion transporter (OAT3) inhibitors. d. Inhibitors of CYP2E1, such as disulfiram.
• •Patients with known allergies or hypersensitivity to iodinated contrast medium and gadolinium-based contrast medium. Known allergies or hypersensitivity to phenol and/or lidocaine and/or their excipients.
• •Patients with a documented history or evidence of alcohol or drug abuse within 1 year of study screening visit 1.
• •Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days of study Screening Visit 1, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration.
• •Patients with clinically significant ECG abnormalities or vital sign abnormalities at during study Screening Visit 1. Patients with ECG or vital sign abnormalities deemed nonclinically significant or unlikely to result in clinical compromise by the Principal Investigator may be considered for study inclusion.
• •Patients with clinically significant laboratory results (as judged by the Principal Investigator).
• •Any condition, in the opinion of the Principal Investigator, that may pose a significant risk to the patient, confound the results of the study or interfere significantly with the patient's participation in the study.