Comparing autologous therapies for knee osteoarthritis treatment
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
PHASE2; PHASE3 · University Health Network, Toronto · NCT05517434
This study is testing whether two types of treatments using your own cells can help people with knee osteoarthritis feel less pain and move better compared to a saline placebo.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 148 (estimated) |
| Ages | 30 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto (other) |
| Locations | 2 sites (Toronto, Ontario and 1 other locations) |
| Trial ID | NCT05517434 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of two autologous cellular treatments—bone marrow aspirate (BMA) and a combination of lipoaspirate micronized (LAM) with leukocyte-poor platelet-rich plasma (LP-PRP)—against a saline placebo for patients with knee osteoarthritis. It is a multi-center, double-blinded, randomized, placebo-controlled trial designed to measure pain relief and functional improvement over a 6-month period. Patient-reported outcomes will be collected at baseline and at 3, 6, and 12 months post-injection to assess the efficacy of the treatments. The study aims to determine if these interventions can significantly reduce pain compared to placebo.
Who should consider this trial
Good fit: Ideal candidates are adults aged 30 and older with unilateral, symptomatic knee osteoarthritis and a pain rating of 4 or higher on the Numeric Pain Rating Scale.
Not a fit: Patients with recent anti-inflammatory injections, significant knee deformities, or other inflammatory arthritis conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, effective treatment option for patients suffering from knee osteoarthritis.
How similar studies have performed: Other studies have shown promise with similar autologous therapies for joint pain, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toronto, Ontario and 1 other locations
- Women's College Hospital — Toronto, Ontario, Canada (NOT_YET_RECRUITING)
- Toronto Western Hospital, University Health Network — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Sowmya Viswanathan, PhD — University Health Network, Toronto
- Study coordinator: Shoba Singh
- Email: Shoba.Singh@uhn.ca
- Phone: 416-634-7240
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Osteoarthritis, Knee, placebo, intra-articular injection, autologous therapy, bone marrow aspirate, lipoaspirate, platelet-rich plasma, leukocyte-poor