Condition: Osteoarthritis, Knee · Sponsor: University Health Network, Toronto
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). BMA, LAM from lipoaspirate (LA), and LP-PRP from whole blood will be prepared using the Cervos Marrow Cellution™ Bone Marrow Aspiration System, Cervos LIPO-PRO™ Adipose Transfer System, and Cervos KEYPRP Platelet Separator System, respectively. Patient-reported outcome (PRO) measures will be collected using web- or paper-based questionnaires administered at baseline (pre-injection) as well as at 3, 6 and 12 months (post-injection). Blood, synovial fluid, and urine samples will be collected at baseline pre-injection and 6 months post-injection only.
This description comes directly from the study's public registry record.
Shoba Singh · 416-634-7240 · Shoba.Singh@uhn.ca
Always discuss trial participation with your own doctor first.
| Women's College Hospital | Toronto, Ontario, Canada | Not Yet Recruiting |
| Toronto Western Hospital, University Health Network | Toronto, Ontario, Canada | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05517434