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.
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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…
Contacts

Shoba Singh

416-634-7240

Shoba.Singh@uhn.ca

CONTACT