• Males or females 18-80 years of age, inclusive

• Diagnosis of OA in one or both knees supported by documentation of clinical and radiographic findings(KL Grades 2-4) up to 6 months prior to screening:

‣ Diagnosis of degenerative or post-traumatic OA of the knee supported by documentation of clinical and radiographic findings up to 6 months prior to screening

⁃ Degenerative meniscal tears allowed as long as there are no pending surgeries

⁃ Flexion Contraction and Valgus/Varus deformity allowed if \< 10 degrees

• Subject must have tried for at least 3 months and failed on at least two of the following pharmacological standard of care therapies in the past 12 months:

‣ Acetaminophen

⁃ NSAID (e.g., ibuprofen, naproxen)

⁃ Opioid (e.g., tramadol)

⁃ Topical NSAID (e.g., diclofenac gel)

⁃ Intra-articular injections (e.g., corticosteroids, hyaluronic acid)

• Subjects knee pain persists for at least 12 weeks prior to screening and does not improve with pain medications (e.g., NSAIDs, acetaminophen, tramadol, etc.) and/or other nonoperative treatment options

• Index knee WOMAC pain subscale score of ≥ 40 on a normalized/standardized scale of 0 to 100 at screening visit Note: The index knee in subjects with bilateral OA of the knees is the one with worse pain with walking. Where both knees have equal pain with walking, then the knee on the subject's dominant side will be designated the index knee.