Efficacy and Safety Trial of PTP-001 (MOTYS) for Symptomatic Knee Osteoarthritis

Exclusion Criteria

• •Participants are excluded from the study if any of the following criteria apply:
• •1. Participant is non-ambulatory (unable to walk \>50 feet without assistance)
• •2. Clinically severe obesity as defined by the National Institutes of Health (body mass target ≥40 kg/m2)
• •3. Contralateral knee pain equal to or exceeding the pain in the target knee (on the WOMAC® NRS3.1 pain questionnaire) at screening and/or baseline
• •4. Clinically significant effusion of the target knee at either the screening or baseline visits determined by physical examination (e.g., ballotable patella or positive bulge sign). Note: Participants presenting with effusion may be enrolled in the study after undergoing knee aspiration to remove excess fluid in the target joint.
• •5. Severe (excessive) malalignment of the tibial-femoral axis, assessed radiographically
• •6. Presence of active infection of the target knee or systemic infection requiring treatment within the 3 months prior to screening
• •7. Clinical diagnosis of inflammatory arthritis (e.g., rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, etc.) established by clinical history, examination, or serology
• •8. Participant is receiving, has received, or plans to receive any of the following therapies
• •* Prior administration of hyaluronic acid, extended release corticosteroid (e.g., Zilretta®), platelet-rich plasma (PRP), or stem cell therapies by intra-articular injection(s) of the target knee within 6 months prior to screening
• •* Prior intra-articular corticosteroid within 3 months prior to screening or into any other joint within 30 days prior to screening
• •* Current chronic systemic use of corticosteroids in doses exceeding 10 mg prednisolone-equivalents daily
• •* Treatment with any investigational therapy (drug, device, or biologic) within 3 months prior to screening or is planned for the duration of the study
• •* Treatment with immunosuppressive medication or chemotherapy within the past 5 years
• •9. Chronic use of narcotics or alcohol abuse within the past 6 months prior to screening
• •10. Surgery to the target knee (including arthroscopy) within 6 months prior to receiving the intra-articular injection or planned surgery to the target knee within 6 months after the injection
• •11. Participant previously underwent arthroplasty of the target knee
• •12. Presence of joint instability or complaints of locking, intermittent limitation in range of motion, or loose body sensation, suggestive of internal derangement of the knee (either extremity)
• •13. Symptomatic OA of the non-target knee that is not responsive to paracetamol (acetaminophen) or oral nonsteroidal anti-inflammatory drugs (NSAIDs).
• •14. Diagnosis of lower extremity gout or pseudo-gout in the past 6 months
• •15. Osteonecrosis of either knee
• •16. Significant acute (within the past 3 months) injury to the target knee
• •17. History of receiving a solid organ or hematologic transplant
• •18. History of malignancy, radiotherapy, or chemotherapy for malignancy within the past 5 years, except for basal or squamous cell carcinoma of the skin
• •19. History of prior radiation therapy of the target knee
• •20. History of autoimmune disease affecting the musculoskeletal system
• •21. Known (documented) history of acquired immune deficiency syndrome or human immunodeficiency virus
• •22. Any condition causing pain in or around the target knee (e.g., radiating pain, pain in another region of the ipsilateral lower extremity) that may interfere with assessment(s) of the target knee
• •23. Other chronic pain anywhere in the body that requires the chronic use of analgesic medications, such as fibromyalgia, neuropathic pain, low back pain, etc.
• •24. Presence of contraindications for use of 3 g/day of orally administered paracetamol/acetaminophen due to known hypersensitivity or hepatic impairment.
• •25. Known presence of any concurrent medical condition (e.g., hematologic renal, hepatic, cardiac, or coagulation abnormalities) that in the investigator's judgment would interfere with the required study assessments and study participation
• •26. Participant is involved in litigation (e.g., worker's compensation) for a medical condition or injury at any anatomical site