Status and phase
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About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Male or female subjects ≥ 40 years old.
The subject must have a clinical diagnosis of osteoarthritis (OA) of one or both knees supported by radiological evidence (Kellgren Lawrence Grade II-IV) which is assessed locally (x-rays within the past 6 months of screening are acceptable).
Subjects whose knee pain persists for at least 12 weeks (about 3 months) prior to screening and does not improve symptoms with pain medications and non-operative treatment options.
Subject who has knee pain ≥ 40 mm out of 100 mm on single question VAS (Visual Analog Scale) at Screening (Visit 1) and prior to Randomization (Visit 2).
Note: Subject should meet this criterion for left and right knee separately to be eligible for bilateral study treatment.
The subject is willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided and has had the opportunity to discuss the study with the investigator or designee.
The subject is able to communicate satisfactorily with the investigator and to participate in, and comply with, the requirements of the study.
The subject is able to understand the nature of the study and any potential hazards associated with participating in it.
Negative pregnancy test for female subjects of childbearing potential.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
374 participants in 2 patient groups
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Central trial contact
Riam Shammaa, MD
Data sourced from clinicaltrials.gov
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