Protocol for the Clinical Evaluation of Lyophilized Amniotic Fluid in the Treatment of Knee Osteoarthritis

Exclusion Criteria

• •1. Subject has active infection at the injection site.
• •2. Subject has rheumatoid arthritis, psoriatic arthritis, or have been diagnosed with any other auto-immune disorders that could be the cause of their knee pain.
• •3. BMI greater than 45 kg/m2
• •4. Subject has received an intra-articular hyaluronic acid (HA) injection for the treatment of OA of the target knee within 12 weeks prior to screening.
• •5. Subject has received a steroid or platelet rich plasma (PRP) injection for the treatment of OA of the target knee within 12 weeks prior to screening.
• •6. Subject has had major surgery or arthroscopy in the target knee within 26 weeks of treatment or plans to have surgery in the target knee within 180 days of treatment.
• •7. Subject is pregnant or plans to become pregnant within 180 days of treatment.
• •8. Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment.
• •9. Subject has any significant medical condition that, in the opinion of the Investigator, would interfere with protocol evaluation and participation.
• •10. Subject has a history of immunosuppressive or chemotherapy in the last 5 years
• •11. Subject has autoimmune disease or a known history of having Acquired Immunodeficiency Syndromes (AIDS) or HIV
• •12. Subject has had prior radiation at the site
• •13. Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin)
• •14. New diagnosis of gout in the past 6 month
• •15. Subject has a diagnosis of osteoarthritis (OA) defined as Grade 4 on the Kellgren Lawrence grading scale.
• •16. Subject has a diagnosis of Osteonecrosis of the knee.
• •17. Subject has had a total knee replacement.