Recruiting
Phase 2
Phase 3

BMA vs. Saline, LAM + LP-PRP vs. Saline

Sponsor:

University Health Network, Toronto

Code:

NCT05517434

Conditions

Osteoarthritis, Knee

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

Interventions

Bone Marrow Aspirate (BMA): Minimally manipulated autologous cellular preparation

Saline (Placebo Comparator for BMA)

Lipoaspirate Micronized + Leukocyte-Poor Platelet-Rich Plasma (LAM + LP-PRP): Minimally manipulated autologous cellular preparations

Saline (Placebo Comparator for LAM + LP-PRP)

Study Details

Brief summary:

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.

Conditions

Osteoarthritis, Knee

Study ID

NCT05517434

Start date

Jan 1, 2025

Status verified date

Apr, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

148 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: For STUDY 1 (ARM A): Bone Marrow Aspirate (BMA)

This group will undergo a bone marrow aspiration and receive an ultrasound guided intra-articular injection of BMA (a single dose of cellular suspension of 9 mL or less)

placebo comparator: For STUDY 1 (ARM C): Saline Injection

This group will undergo a bone marrow aspiration and receive an ultrasound guided intra-articular injection of saline solution (9 mL)

experimental: For STUDY 2 (ARM B): Lipoaspirate Micronized + Leukocyte-Poor Platelet-Rich Plasma (LAM + LP-PRP)

This group will undergo a blood collection plus lipoaspiration and receive an ultrasound guided intra-articular injection of LAM (a single dose of cellular suspension of 9 mL or less) followed by LP-PRP (a single dose of cellular suspension of 2 mL or less)

placebo comparator: For STUDY 2 (ARM D): Saline Injection

This group will undergo a blood collection plus lipoaspiration and receive ultrasound guided intra-articular injections of saline solution (9 mL followed by 2 mL)

Interventions

Bone Marrow Aspirate (BMA): Minimally manipulated autologous cellular preparation

Participants will undergo a bone marrow aspiration. About 10 mL of BMA will be collected from the posterior iliac spine i.e., ipsilateral and/or contralateral iliac crest using the Cervos Marrow Cellution™ kit. The BMA does not require processing using a centrifuge after collection. 9 mL (or less) of BMA is injected into the osteoarthritic knee joint after collection (Arm A, Study 1).

Saline (Placebo Comparator for BMA)

Participants will undergo a bone marrow aspiration to collect about 10 mL of BMA from the posterior iliac spine i.e., ipsilateral and/or contralateral iliac crest. However, 0.9% sodium chloride (NaCl) Baxter or equivalent (9 mL) is injected into the osteoarthritic knee joint (Arm C, Study 1).

Lipoaspirate Micronized + Leukocyte-Poor Platelet-Rich Plasma (LAM + LP-PRP): Minimally manipulated autologous cellular preparations

Participants will undergo a lipoaspiration. 40 mL of lipoaspirate (LA) will be collected from subcutaneous adipose tissue. LA will be processed using the Cervos LIPO-PRO™ kit and a centrifuge. Participants will also undergo a blood draw. About 30 mL of whole blood will be collected from the antecubital fossa. Whole blood will be processed using the Cervos KEYPRP kit and a centrifuge. After processing, 9 mL (or less) of LAM is injected first followed immediately by 2 mL (or less) of LP-PRP into the osteoarthritic knee joint (Arm B, Study 2).

Saline (Placebo Comparator for LAM + LP-PRP)

Participants will undergo a lipoaspiration to collect 40 mL of LA and a blood draw to collect about 30 mL of whole blood. However, 0.9% of sodium chloride (NaCl) Baxter or equivalent is injected twice (9 mL + 2 mL) into the osteoarthritic knee joint (Arm D, Study 2).

Primary outcome measure

  • Pain Level Changes. Differences in response rates between groups (treatments vs placebos) at 6-months (end of study) compared to baseline. Response is based on an improvement of 2 units or more in the Numeric Pain Rating Scale (NPRS). [ Time Frame: baseline (pre-injection) and 3, 6 and 12 months (post-injection) ]

Central Contacts and Locations

Central contacts

Anu Thomas

416-634-7240Anu.Thomas2@uhn.ca

Rania Khalil

Rania.Khalil@uhn.ca

Locations

Toronto Western Hospital, University Health Network

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Shoba Singh

416-634-7240Shoba.Singh@uhn.ca

Principal Investigator:

Christian Veillette, MD, MSc, FRCSC

More Information

Sponsor

University Health Network, Toronto

Last update posted

Aug 27, 2026

Last verified

Apr, 2026

Keywords

  • placebo
  • intra-articular injection
  • autologous therapy
  • bone marrow aspirate
  • lipoaspirate
  • platelet-rich plasma
  • leukocyte-poor
  • pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-08-27.