Actively Recruiting
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
Led by University Health Network, Toronto · Updated on 2025-12-19
148
Participants Needed
2
Research Sites
26 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
Researchers are evaluating two minimally manipulated autologous cellular treatments for knee osteoarthritis (OA) in a phase II/III multi-center, double-blinded, randomized, placebo-controlled trial. The study compares bone marrow aspirate (BMA) injection and a combination of lipoaspirate micronized (LAM) with leukocyte-poor platelet-rich plasma (LP-PRP) injections against placebo saline injections. The goal is to measure pain improvement and functional outcomes in adults with knee OA. Participants will receive either an intra-articular injection of BMA collected from bone marrow aspiration or an injection of LAM plus LP-PRP prepared from lipoaspirate and whole blood. Each treatment is compared to a placebo saline injection group. Bone marrow aspiration or lipoaspiration plus blood draw are performed before injections. Injections are ultrasound-guided and given as a single dose. Two independent studies are conducted under one protocol, each with a treatment and placebo group. Participants will complete patient-reported outcome questionnaires at baseline, 3, 6, and 12 months post-injection. Biological samples including blood, synovial fluid, and urine will be collected at baseline and 6 months. Safety is monitored through adverse event reporting and X-rays at 6 months. The main outcome is a pain score improvement at 6 months. Other measures include functional scores, health-related quality of life, treatment satisfaction, and health care usage. Total participation lasts up to 12 months post-injection.
CONDITIONS
Brief 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
- Signed consent for study participation
- Baseline Numeric Pain Rating Scale (NPRS) score of 4 points or higher
- Chronic, symptomatic knee pain in at least one knee; if both knees affected, the more severe knee will be treated
- Kellgren-Lawrence (KL) 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...
- Anti-inflammatory knee injections (including corticosteroids, Synvisc, PRP, nSTRIDE) within the past 6 months
- Major axial knee deviation (varus or valgus greater than 10 degrees)
- Knee lesions causing pain or swelling (ligament, meniscus, osteochondral injury)
- Active infection in the treated knee
- Diagnosed inflammatory arthritis or related diseases (rheumatoid arthritis, psoriatic arthritis, gout, etc.)
- Diagnosed blood cancers or ongoing/planned chemotherapy
- Venous or lymphatic stasis in the treated leg
- Allergy to local anesthetics
- Blood clotting disorders such as hemophilia
- Arthroscopic knee surgery within the past 6 months
- Daily opioid use for past 3 months or recent NSAID use within 1 week
- Use of systemic corticosteroids for chronic conditions within past 3 months
- Immunosuppression or acute infections
- For Study 1: inability to tolerate bone marrow aspiration or insufficient bone marrow collection after two attempts
- For Study 2: inability to tolerate lipoaspiration or insufficient lipoaspirate collection after two attempts
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants receive a single ultrasound guided intra-articular injection after either bone marrow aspiration or lipoaspiration and blood collection, depending on their assigned group.
1 injection visit (in-person)
Duration - 12 months post-injection
Participants are followed to assess pain levels, knee function, safety, and overall satisfaction after injection.
Visits at 3, 6, and 12 months post-injection (in-person or remote)
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
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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