Autologous BMA vs Saline and LAM + LP-PRP vs Saline Evaluations in Knee OA
Recruiting
Phase 2
Phase 3
Interventional Study
Osteoarthritis, Knee
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 30 and older
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 148 (estimated)
- Sponsor
- University Health Network, Toronto · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
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 chr…
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