APSS-33-00: A Multicenter, Pilot Study of Autologous Protein Solution (APS) in Knee Osteoarthritis (OA)

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Pilot Study of a Single, Intra-Articular Injection of Autologous Protein Solution (APS) in Patients With Osteoarthritis (OA) of the Knee

This double-blind, multicenter, randomized, controlled trial (RCT) will evaluate the efficacy of a single dose of Autologous Protein Solution (APS) in patients with osteoarthritis (OA) of the knee who have failed at least 1 conservative osteoarthritis (OA) therapy (e.g. physiotherapy, simple analgesics, intra-articular injection).

A double-blind, multicenter, randomized, controlled trial (RCT) that will evaluate the efficacy of a single dose of Autologous Protein Solution (APS) in patients with Osteoarthritis (OA) of the knee who have failed at least 1 conservative OA therapy (e.g. physiotherapy, simple analgesics, intra-articular injection).

Inclusion Criteria:

• Male or female ≥40 years and ≤75 years.
• Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions.
• Diagnosis of knee osteoarthritis (OA) Grade 2 or 3 according to the Kellgren-Lawrence scale
• Body mass index (BMI) ≤ 40.
• Failed at least 1 conservative OA therapy
• Signed an independent ethics committee (IEC) approved informed consent form (ICF).

Main Exclusion Criteria:

• Intra-articular Hyaluronic (HA) injection within 6 months- On Day 1 (pre-injection), presence of active infection or abnormal effusion in the knee as noted by a physical examination (e.g., erythema, redness, heat, swelling).
• Presence of symptomatic OA in the non-study knee.
• Diagnosed with rheumatoid arthritis (RA), Reiter's syndrome, psoriatic arthritis, ankylosing spondylitis, chondromalacia, arthritis secondary to other inflammatory diseases (e.g., inflammatory bowel disease [IBD], sarcoidosis, or amyloidosis) or of metabolic origin.
• Diagnosis of isolated patella-femoral joint osteoarthritis.
• Valgus/varus deformity judged by the investigator to be clinically significant.
• Disease of spine, hip or other lower extremity joints of sufficient degree to affect assessment of the signal knee. Patients with TKR at the contra-lateral knee or THR in either hip may be enrolled provided sufficient pain relief after TKR or THR which does not require additional analgesic relief.
• Untreated acute traumatic injury of the index knee.
• Presence of a symptomatic meniscal tear in the index knee
• Limited daily activity for reasons other than OA.
• Presence of surgical hardware or other foreign body in the index knee.