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

Inclusion Criteria:

• Patient is a candidate for non-surgical intervention of the knee
• Patient must be between the ages of 21 and 80 years old
• Patient must have a diagnosis of osteoarthritis (OA) of the knee defined as grade 1 to 3 on the Kellgren-Lawrence grading scale

Exclusion Criteria:

• Patient has a diagnosis of osteoarthritis with a Kellgren-Lawrence grade of 4
• Patient has a BMI greater than 40 kg/m2, active infection at the injection site,symptomatic OA of the contralateral knee or of either hip that is not responsive toacetaminophen (Tylenol) and requires other therapy
• Patient has rheumatoid arthritis, psoriatic arthritis or diagnosis with any otherdisorder that is the primary source of their knee pain
• Patient has an autoimmune disease or known history of having Acquired ImmunodeficiencySyndrome (AIDS) or HIV
• Patient has any of the following treatments to the target knee within 12 weeks priorto screening
• Intra-articular hyaluronic acid (HA) injection
• Steroid or platelet rich plasma (PRP) injection
• Use of any investigational drug, device, or biologic
• Patient had or is planning to have major surgery or arthroscopy in the target kneewithin 26 weeks of treatment
• Patient has a history of partial or total knee arthroplasty
• Patient has undergone immunotherapy or chemotherapy in the last 5 years, priorradiation at the site, or is currently taking a narcotic medication for any reason
• Patient is pregnant or plans to become pregnant within 365 days of treatment
• Patient has any significant medical condition that would interfere with protocolevaluation and participation
• Patient is a recipient of worker's compensation
• Patient is a current prisoner