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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 148 participants in total. It began in 2025-01-01 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 (\<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
Contact & Investigator
Sowmya Viswanathan, PhD
PRINCIPAL INVESTIGATOR
University Health Network, Toronto
Frequently Asked Questions
Who can join the NCT05517434 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, studying Osteoarthritis, Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05517434 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05517434 currently recruiting?
Yes, NCT05517434 is actively recruiting participants. Contact the research team at Shoba.Singh@uhn.ca for enrollment information.
Where is the NCT05517434 trial being conducted?
This trial is being conducted at Toronto, Canada, Toronto, Canada.
Who is sponsoring the NCT05517434 clinical trial?
NCT05517434 is sponsored by University Health Network, Toronto. The principal investigator is Sowmya Viswanathan, PhD at University Health Network, Toronto. The trial plans to enroll 148 participants.