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Autologous BMA vs Saline and LAM + LP-PRP vs Saline Evaluations in Knee OA

Study acronym: ABLE-OA
StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 5 months later Jun 2026 → Dec 2028
See other at-risk trials from University Health Network, Toronto

Record History

  1. Primary completion pushed from Jun 2026 to Dec 2028 Completion pushed from Dec 2026 to Dec 2028v8 Show 1 more changeShow less
    • Completion pushed from Dec 2026 to Dec 2028
  2. Eligibility criteria expanded, about 21 words Study description expanded, about 63 wordsv7 Show 1 more changeShow less
    • Study description expanded, about 63 words

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Dec 2024 to Jan 1, 2025 · Site details revised at 2 of 2 sitesv6 Show 2 more changesShow less
    • Start date changed from estimate of Dec 2024 to Jan 1, 2025
    • Site details revised at 2 of 2 sites
  4. Start date: Sep 2024 to Dec 2024 Study sites: 3 to 2 · Collaborators: 2 to 1v5 Show 2 more changesShow less
    • Study sites: 3 to 2
    • Collaborators: 2 to 1

    See this version in full on ClinicalTrials.gov ↗

  5. Start date: Jun 2024 to Sep 2024 Site contacts updated at 3 of 3 sitesv4 Show 1 more changeShow less
    • Site contacts updated at 3 of 3 sites
Show 2 earlier versionsHide 2 earlier versions
  1. Primary completion date: Sep 2025 to Jun 2026 Start date: Jan 2024 to Jun 2024 · Completion date: Mar 2026 to Dec 2026 · Interventions: Bone Marrow Aspirate Concentrate (BMAC): Minimally manipulated, concentrated autologous cellular preparation (Biological), Lipoaspirate +… to Bone Marrow Aspirate (BMA): Minimally manipulated autologous cellular preparation (Biological), Lipoaspirate Micronized + Leukocyte-Poor… · 4 morev3 Show 7 more changesShow less
    • Start date: Jan 2024 to Jun 2024
    • Completion date: Mar 2026 to Dec 2026
    • Interventions: Bone Marrow Aspirate Concentrate (BMAC): Minimally manipulated, concentrated autologous cellular preparation (Biological), Lipoaspirate +… to Bone Marrow Aspirate (BMA): Minimally manipulated autologous cellular preparation (Biological), Lipoaspirate Micronized + Leukocyte-Poor…
    • Eligibility criteria expanded, about 10 words
    • Study description revised
    • Site contacts updated at 1 of 3 sites
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion date: Jun 2024 to Sep 2025 Start date: Oct 2022 to Jan 2024 · Completion date: Dec 2024 to Mar 2026v2 Show 2 more changesShow less
    • Start date: Oct 2022 to Jan 2024
    • Completion date: Dec 2024 to Mar 2026
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05517434
Lead Sponsor University Health Network, Toronto
Collaborators: Women's College Hospital
Conditions Osteoarthritis, Knee
Enrollment 148 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov