A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee

Exclusion Criteria

• •Kellgren and Lawrence radiographic grade 1 OA of the knee
• •Use of pain medication less than 5 days before the baseline visit
• •Regular use of anticoagulants
• •Symptoms that could indicate meniscal displacement or an IA loose body.
• •Corticosteroid injection into the index knee within 3 months prior to screening.
• •Viscosupplement or any other autologous or allogeneic product into the index knee within 6 months prior to screening.
• •Patients with known hypersensitivity reactions to ASA or any of its constituents.
• •Knee surgery on the index knee within 12 months prior to screening and/or planned knee surgery during the study
• •Knee surgery on the contralateral knee within 6 months prior to screening and/or planned knee surgery during the study
• •Acute index knee trauma within 3 months prior to screening
• •Knee effusion requiring aspiration of the index or contralateral knee within 3 months prior to screening.
• •Contralateral knee pain above limits defined in the protocol
• •Current therapy with any immunosuppressive therapy or medical conditions likely to require systemic steroids during the study.
• •Any active or systemic infection including infection of the index knee joint or breakdown or disease of the index knee skin/soft tissues.
• •Clinically significant intercurrent illness, medical condition, non-knee pain, or medical history that would jeopardize patient safety, limit participation, or compromise interpretation of data derived from the patient
• •Active alcohol or substance use disorder, or any other reason that would make it unlikely that the patient will comply with study procedures
• •Females who are pregnant or lactating
• •Participation in another clinical trial within the 30 days (or 5 half-lives of the investigational compound, whichever is longer) before screening.