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

Approximately 180 subjects will be enrolled in one of three dose arms ( 4ml, Saline Placebo and 4ml 2x). The estimated enrollment period is 6 months. Each subject will receive 1 injection and be evaluated for efficacy and safety during a 6 month observation period. The study is expected to be completed within 12 months, inclusive of enrollment and follow-up for all subjects.

Inclusion criteria

• Subject is 30 years or older.
• Subject has a diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale.
• Subject is willing and able provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study.
• Subject must have a VAS pain scale greater than 30.

Exclusion criteria

• Subject has active infection at the injection site.
• 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.
• BMI greater than 45 kg/m2
• 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.
• 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.
• 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.
• Subject is pregnant or plans to become pregnant within 180 days of treatment.
• Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment.
• Subject has any significant medical condition that, in the opinion of the Investigator, would interfere with protocol evaluation and participation.
• Subject has a history of immunosuppressive or chemotherapy in the last 5 years
• Subject has autoimmune disease or a known history of having Acquired Immunodeficiency Syndromes (AIDS) or HIV
• Subject has had prior radiation at the site
• Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin)
• New diagnosis of gout in the past 6 month
• Subject has a diagnosis of osteoarthritis (OA) defined as Grade 4 on the Kellgren Lawrence grading scale.
• Subject has a diagnosis of Osteonecrosis of the knee.
• Subject has had a total knee replacement.