NCT06216028

Bone Marrow Aspirate Concentrate (BMAC) Treatment for Knee Osteoarthritis

Bone Marrow Aspirate ConCentrate for the Treatment of knEe Osteoarthritis: A Phase III, muLti-centER, Pan-cAnadian, prospecTivE Trial

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 374 (estimated)
• Sponsor: CELL Technologies Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the ACCELERATE3 trial is to assess the efficacy of a single intra-articular (IA) injection of autologous BMAC, in one or both knees, compared to a single IA injection of Standard of Care (SOC) in patients with mild to severe knee OA.

Detailed description

A Pan-Canadian, Phase 3, open-label, randomized trial of bone marrow aspirate concentrate (BMAC) administration in patients with mild to severe knee OA. A total of 374 eligible patients will be randomized to BMAC or Standard of Care (SOC). Patients randomized to the interventional arm (BMAC) will have a sample of bone marrow taken (from their pelvic region) and processed at the bedside for immediate delivery back to the patient via intra-articular (IA) injection into one or both knees. All randomized patients will be followed for 48 weeks. Blood will be collected at scheduled visits for analysis. Adverse events will be monitored throughout the trial. Assessments will be performed by physical exam and standardized questionnaires related to the physical function, health, and pain of each participant will be conducted.

Conditions

• Knee Osteoarthritis
• Musculoskeletal Diseases

Interventions

Type	Name	Description
BIOLOGICAL	Autologous Bone Marrow Aspirate Concentrate	Range of between 18.7 X 104 cells/mL and 21.8 X 106 cells/mL total nucleated cells (TNC)

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-08-01
• Completion: 2026-12-01
• First posted: 2024-01-22
• Last updated: 2024-05-24

Locations

1 site across 1 country: Canada