Can your own cells fix your knee? new trial tests bone marrow and fat injections against placebo
NCT ID NCT05517434
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 2 times
Summary
This study tests whether injecting a person's own bone marrow cells or a mix of fat cells and platelet-rich plasma into the knee can reduce pain from osteoarthritis. About 148 adults with moderate knee arthritis will receive either the real treatment or a placebo (salt water) injection. Researchers will track pain and function for 12 months to see if these natural cell treatments work better than a dummy shot.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 148 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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30 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Toronto Western Hospital, University Health Network
RECRUITINGToronto, Ontario, M5T 2S8, Canada
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Women's College Hospital
NOT_YET_RECRUITINGToronto, Ontario, M5S 1B2, Canada
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Other studies related to the condition(s) this trial covers.
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- Gel shot vs standard injection: which quiets arthritic knees?