Autologous BMA vs Saline and LAM + LP-PRP vs Saline Evaluations in Knee OA

ABLE OA is a Health Canada authorized (phase II/III) trial \[Parent Control #: 263591\]. A multi-center, prospective, double-blinded, randomized, placebo-controlled adaptive trial to evaluate the efficacy of two minimally manipulated autologous cellular preparations i) bone marrow aspirate (BMA) injection; and, ii) combined lipoaspirate micronized (LAM) and leukocyte poor (LP) platelet-rich plasma (PRP) injections for the treatment of knee osteoarthritis (OA). BMA, LAM from lipoaspirate (LA), and LP-PRP from whole blood will be prepared using the Cervos Marrow Cellution™ Bone Marrow Aspiration System, Cervos LIPO-PRO™ Adipose Transfer System, and Cervos KEYPRP Platelet Separator System, respectively. Patient-reported outcome (PRO) measures will be collected using web- or paper-based questionnaires administered at baseline (pre-injection) as well as at 3, 6 and 12 months (post-injection). Blood, synovial fluid, and urine samples will be collected at baseline pre-injection and 6 months post-injection only.

Inclusion Criteria: * Male or female at least 30 years of age at the time of screening * Willingness and ability to comply with study procedures and visit schedules and able to follow oral and written instructions * Signed consent for study participation * Baseline NPRS ≥ 4 points * Presence of chronic, symptomatic knee pain in at least one knee; if both knees are affected, the knee with greater severity will be selected for treatment * KL grade 2 or 3 knee OA based on standing knee X-ray assessment * Body mass index ≤ 30 kg/m2 Exclusion Criteria: * Approved anti-inflammatory therapy injections (corticosteroid, Synvisc, PRP, nSTRIDE-Autologous Protein Solution) within the previous 6 months in the knee * Major axial deviation (varus \>10°, valgus \>10°) * Any concomitant knee lesion causing pain or effusion (i.e., ligamentous or meniscal injury, osteochondral lesion) * Presence of clinically observed active infection in the index knee * Diagnosed with rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis, or arthritis secondary to other inflammatory diseases; chondrocalcinosis, Paget's disease, or villonodular synovitis * Diagnosed with leukemia or other hematologic cancers, known presence of metastatic malignant cells, or ongoing or planned chemotherapeutic treatment * Presence of venous or lymphatic stasis in the index leg * A history of local anesthetic allergy * Medical conditions such as hemophilia or other blood clotting disorders * Arthroscopic knee surgery within the previous 6 months * Daily opioid use for the past 3 months, use of non-steroidal anti-inflammatory drugs within 1 week of the procedure, unable to hold anti-platelet medications * Use of systemic corticosteroids for treatment of a chronic medical condition within the past 3 months * Immunosuppression or acute infective processes Study Treatment Exclusion: * For Study 1: Inability to tolerate the bone marrow aspiration procedure resulting in insufficient collection of BMA (\