Actively Recruiting
Autologous BMA vs Saline and LAM + LP-PRP vs Saline Evaluations in Knee OA
Led by University Health Network, Toronto · Updated on 2025-12-19
148
Participants Needed
2
Research Sites
99 weeks
Total Duration
On this page
Sponsors
U
University Health Network, Toronto
Lead Sponsor
W
Women's College Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Autologous BMA vs Saline and LAM + LP-PRP vs Saline Evaluations in Knee OA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 Numeric Pain Rating Scale (NPRS) score of 4 points or higher
- Presence of chronic, symptomatic knee pain in at least one knee; if both knees are affected, the more severe knee will be treated
- Kellgren-Lawrence grade 2 or 3 knee osteoarthritis based on standing knee X-ray
- Body mass index (BMI) of 30 kg/m2 or less
You will not qualify if you...
- Received approved anti-inflammatory injections (corticosteroid, Synvisc, PRP, nSTRIDE) in the knee within the past 6 months
- Major axial knee deviation (varus or valgus greater than 10 degrees)
- Any knee injury causing pain or swelling such as ligament, meniscus, or osteochondral lesions
- Active infection in the knee
- Diagnosed with rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis, or other inflammatory arthritis; chondrocalcinosis, Paget's disease, or villonodular synovitis
- Diagnosed with leukemia or other blood cancers, metastatic cancer, or undergoing/planning chemotherapy
- Presence of venous or lymphatic stasis in the affected leg
- Allergy to local anesthetics
- Blood clotting disorders such as hemophilia
- Arthroscopic knee surgery within the last 6 months
- Daily opioid use for the past 3 months, recent use of NSAIDs within 1 week, or inability to stop anti-platelet medications
- Use of systemic corticosteroids for chronic conditions within the past 3 months
- Immunosuppression or active infection
- For Study 1: inability to tolerate bone marrow aspiration with insufficient BMA collected after two attempts
- For Study 2: inability to tolerate lipoaspiration with insufficient lipoaspirate collected after two attempts
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B2
Not Yet Recruiting
2
Toronto Western Hospital, University Health Network
Toronto, Ontario, Canada, M5T 2S8
Actively Recruiting
Research Team
S
Shoba Singh
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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