NCT05517434 Autologous BMA vs Saline and LAM + LP-PRP vs Saline Evaluations in Knee OA
| NCT ID | NCT05517434 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | University Health Network, Toronto |
| Condition | Osteoarthritis, Knee |
| Study Type | INTERVENTIONAL |
| Enrollment | 148 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2026-06 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
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 synd