Micronized dHACM vs. Saline in the Treatment of Osteoarthritis of the Knee

Exclusion Criteria

• •1. Subject has a diagnosis of osteoarthritis (OA) defined as Grade 4 on the Kellgren Lawrence grading scale
• •2. BMI greater than 40 kg/m\^2
• •3. Subject has active infection at the injection site
• •4. Symptomatic OA of the contralateral knee or of either hip that is not responsive to acetaminophen (Tylenol®) and requires other therapy.
• •5. Subject has rheumatoid arthritis, psoriatic arthritis, or have been diagnosed with any other disorders that is the primary source of their knee pain, including but not limited to: osteonecrosis, radiculopathy, bursitis, tendinitis, tumor, cancer
• •6. Subject has documented history of gout or pseudo-gout
• •7. Subject has autoimmune disease or a known history of having Acquired Immunodeficiency Syndromes (AIDS) or HIV
• •8. Subject has received any of the following to the target knee:
• •1. Intra-articular hyaluronic acid (HA) injection within 12 weeks prior to screening
• •2. Steroid or platelet rich plasma (PRP) injection within 12 weeks prior to screening
• •3. Has had or is planning to have major surgery or arthroscopy in the target knee within 26 weeks of treatment
• •4. History of a total knee arthroplasty
• •9. Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment
• •10. Subject has a history of immunosuppressive or chemotherapy in the last 5 years
• •11. Subject has had prior radiation at the site
• •12. Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin)
• •13. Subject is pregnant or plans to become pregnant within 365 days of treatment
• •14. Subject has any significant medical condition that, in the opinion of the Investigator, would interfere with protocol evaluation and participation
• •15. Subject is a worker's compensation patient
• •16. Subject is a prisoner