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Compares treatment options for Osteoarthritis, Knee
Official title Autologous BMA vs Saline and LAM + LP-PRP vs Saline Evaluations in Knee OA
ClinicalTrials.gov ID: NCT05517434
What this study is testing
What is Bone Marrow Aspirate (BMA): Minimally manipulated autologous cellular preparation?
Bone Marrow Aspirate (BMA): Minimally manipulated autologous cellular preparation is an investigational medicine, given as an once-daily injectable medicine, being studied as a potential treatment for osteoarthritis, knee.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 and older
You may be able to join if
- 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...
You likely can't join if
- Approved anti-inflammatory therapy injections (corticosteroid, Synvisc, PRP, nSTRIDE-Autologous Protein Solution) within the previous 6 months in the...
- 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...
- Diagnosed with leukemia or other hematologic cancers, known presence of metastatic malignant cells, or ongoing or planned chemotherapeutic treatment
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.