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

Trial details

Who runs it

University Health Network, Toronto

Trial code

NCT05517434

Record updated

27 August 2026

Original description

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).Read full original descriptionShow less

Intra-Articular Autologous Bone Marrow Aspirate vs Placebo Injection and Lipoaspirate Micronized With Leukocyte-Poor Platelet Rich Plasma vs Placebo Injection Evaluations for Treatment of Knee OsteoArthritis: The ABLE OA Double-Blinded Randomized Clinical Trial

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: 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: Approved anti-inflammatory therapy injections (corticosteroid, Synvisc, PRP, nSTRIDE-Autologous Protein Solution) within the previous 6 months in the knee; Any concomitant knee lesion causing pain or effusion (i.e., ligamentous or meniscal injury, osteochondral lesion); Arthroscopic knee surgery within the previous 6 months; 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; A history of local anesthetic allergy; Medical conditions such as hemophilia or other blood clotting disorders; Use of systemic corticosteroids for treatment of a chronic medical condition within the past 3 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; Major axial deviation (varus >10°, valgus >10°); Presence of venous or lymphatic stasis in the index leg; 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 (<10 mL) after two successive aspiration attempts; For Study 2: Inability to tolerate the lipoaspiration procedure resulting in insufficient collection of LA (<40 mL) after two successive aspiration attempts.

ClinicalTrials.gov NCT05517434