Autologous Conditioned Plasma (ACP) Intra-articular (IA) Injections for Knee Osteoarthritis (OA)

This study is a prospective, multi center randomized double blind, two arm study.

90 subjects will be randomized to receive injections of either Autologous Conditioned Plasma Intra-articular or the control.

Inclusion criteria

• The subject is 18 to 70 years of age.
• The subject presents with complaints of continued pain of primary knee for at least 6 weeks.
• The subject has documented radiographs evidence of Osteoarthritis (OA) in the tibio-femoral or patella-femoral compartment of the target knee (Kellgren-Lawrence Grades II-III), using radiographs performed within 24 weeks of screening.
• The subject has a WOMAC pain score of at least 8 out of 20 and at least moderate pain (a score of 2) for at least 2 questions on activities

Exclusion criteria

• Grade I and IV on the knee Kellgren-Lawrence grading scale
• Subject has clinically 3+ effusion of the target knee (stroke test grading system).
• Subject has significant (> 10⁰) valgus or varus deformities as evidenced by standard of care X-ray.
• Subject has had systemic or IA injection of corticosteroids in any joint within three months prior to screening.
• Viscosupplementation in any joint in the past six months.
• Subject has an increased risk for post- procedure bleeding (e.g., bleeding disorder or taking anticoagulants except low-dose aspirin).
• Subject had prior open surgery on the target knee within 12 months or knee arthroscopy within 6 months
• Subject has inflammatory disease of either knee other than OA.
• Subject with underlying medical conditions that could interfere with the evaluation of the outcome.
• Subject with positive pregnancy test, or breast feeding.
• Subject with plans to participate in other clinical trial involving medical or surgical intervention in the next 12 months.
• Subject with any condition (including cognitive impairment) that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
• Subject has rheumatoid arthritis or gout
• Subject has a history of or a current infection at the affected joint.
• Subject with plans to undergo any elective orthopedic surgery in the next 12 months.
• Subject requires pain management therapy (with the exception of acetaminophen) not related to the target knee.