An Amniotic Membrane Injection Comparing Two Doses (1 mL and 2mL Injection) in the Treatment of Osteoarthritis of the Knee

Exclusion Criteria

• •Subject has a diagnosis of osteoarthritis (OA) defined as Grade 4 on the Kellgren Lawrence grading scale
• •BMI greater than 40 kg/m2
• •Subject has active infection at the injection site
• •Symptomatic OA of the contralateral knee or of either hip that is not responsive to acetaminophen (Tylenol) and requires other therapy.
• •Subject has rheumatoid arthritis, psoriatic arthritis or has been diagnosed with any other disorder that is the primary source of their knee pain, including but not limited to: osteonecrosis, radiculopathy, bursitis, tendinitis, tumor or cancer
• •Subject has documented history of gout or pseudo-gout
• •Subject has an autoimmune disease or known history of having Acquired Immunodeficiency Syndromes (AIDS) or HIV
• •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. Intra-articular cortisone (steroid/corticosteroid) injection into the knee joint within 12 weeks of treatment
• •3. Steroid or platelet rich plasma (PRP) injection within 12 weeks prior to screening
• •4. Has had or is planning to have major surgery or arthroscopy in the target knee within 26 weeks of treatment
• •History of partial or total knee arthroplasty
• •Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment
• •Subject has a history of immunosuppressive or chemotherapy in the last 5 years
• •Subject has had prior radiation at the site
• •Subject is currently taking narcotic medication for any reason.
• •Subject is pregnant or plans to become pregnant within 365 days of treatment
• •Subject has any significant medical condition that, in the opinion of the Investigator, would interfere with protocol evaluation and participation
• •Subject is a worker's compensation patient
• •Subject is a prisoner