Evaluation of Intra-articular Injection of Autologous Protein Solution ("APS(TM)") for the Treatment of Osteoarthritis (OA)

A Prospective Single-Center Clinical Study of a Single Intra-Articular Injection of Autologous Protein Solution ("APS(TM)") in Patients With Osteoarthritis (OA) of the Knee

This prospective single-center study will evaluate the safety and tolerability of a single dose of "APS(TM)" treated patients with OA of the knee who have failed conservative OA therapy. The study will also evaluate efficacy by assessing patient pain and functionality.

Eligibility Criteria:

• Male or female ≥40 years.
• Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions.
• A standing radiograph of the knee showing a Kellgren grade of 2 or 3
• Frequency of knee pain on most days over the last month.
• Diagnosis of unilateral knee OA
• Body mass index (BMI) ≤40 kg/m2.
• Failed conservative OA therapy.
• Signed an independent ethics committee (IEC)-approved informed consent form (ICF).
• Willingness to abstain from the use of topical pain therapies, intra-articular corticosteroids, and viscosupplementation during the study.
• Willingness to abstain from systemic pain medications except rescue medication.