Comparing autologous therapies for knee osteoarthritis treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Toronto Western Hospital, University Health Network
  Toronto, Ontario, Canada Recruiting
• Women's College Hospital
  Toronto, Ontario, Canada Not yet recruiting

Study contacts

• Principal investigator: Sowmya Viswanathan, PhD — University Health Network, Toronto
• Study coordinator: Anu Thomas
• Email: Anu.Thomas2@uhn.ca
• Phone: 416-634-7240

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.