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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | No Intervention | Standard of care IA injection may include cortisone or hyaluronic acid (HA) as per discretion of the Principal Investigator | |
| Bone Marrow Aspirate Concentrate (BMAC) | Experimental | Cell suspension for infusion. 50 mL of Bone Marrow Aspirate collected, and 10-15 mL BMAC injected to knee(s) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Bone Marrow Aspirate Concentrate | Biological | Range of between 18.7 X 104 cells/mL and 21.8 X 106 cells/mL total nucleated cells (TNC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC® Pain Subscore | To assess the efficacy of a single intra-articular (IA) injection of autologous BMAC, in one or both knees, compared to single IA injection of Standard of Care (SOC) in patients with mild to severe knee osteoarthritis (OA). The Western Ontario and McMaster Universities Arthritis Index (WOMAC) questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Possible score range of 0-20 for Pain (Higher scores = worse outcome). | Change in WOMAC® Pain Subscore (Section A, Items #1-5) as measured by VAS from Baseline to the end of Week 12. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety (Baseline to Day 30 post IA injection) | To assess the safety of IA injection(s) of autologous BMAC compared to SOC in patients with knee OA. | Incidence and severity of immediate adverse events (AEs) for 30 minutes following IA injection; Incidence and severity of any AE for 30 days following IA injection; Incidence of Serious Adverse Events (SAEs) |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory - Economic | Conduct an iterative health economic evaluation to examine the potential cost effectiveness of BMAC for the treatment of OA and the value of future research on mesenchymal stem cells (MSCs). | To determine the effect of IA injection(s) of autologous BMAC in promoting health economic outcomes, compared to controls |
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Riam Shammaa, MD | Contact | 437-985-1505 | info@celltechnologies.net |
| Name | Affiliation | Role |
|---|---|---|
| Riam Shamma, MD | CELL Technologies Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canadian Centres for Regenerative Therapy (CCRT) | Toronto | Ontario | Canada |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D009140 | Musculoskeletal Diseases |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D012216 | Rheumatic Diseases |
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| WOMAC® Physical Function Subscore | To assess the change in the quality of life achieved by IA injection(s) of autologous BMAC compared to SOC in patients with knee OA. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Possible score range of 0-68 for Physical (Higher scores = worse outcome). | Change in WOMAC® Physical Function Subscore (Section C, Items #8-24) as measured by VAS from Baseline to the end of Week 12. |
| WOMAC® Pain Subscore | To assess the change in the quality of life achieved by IA injection(s) of autologous BMAC compared to SOC in patients with knee OA. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Possible score range of 0-20 for Pain (Higher scores = worse outcome). | Percentage of subjects classified as 'responders' as measured by improvement in WOMAC® Pain Subscore at Week 12 |
| WOMAC® Physical Function Subscore | To assess the change in the quality of life achieved by IA injection(s) of autologous BMAC compared to SOC in patients with knee OA. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Possible score range of 0-68 for Physical (Higher scores = worse outcome). | Percentage of subjects classified as 'responders' as measured by improvement in WOMAC® Physical Function Subscore at Week 12 |
| WOMAC® Physical Function and Pain Subscore | To assess the change in the quality of life achieved by IA injection(s) of autologous BMAC compared to SOC in patients with knee OA. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Possible score range of 0-20 for Pain and 0-68 for Physical (Higher scores = worse outcome). | Percentage of subjects classified as 'responders' as measured by a composite responder analysis at Week 12. |
| WOMAC® Total Score | To assess the change in the quality of life achieved by IA injection(s) of autologous BMAC compared to SOC in patients with knee OA. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Possible score range of 0-96 for a Total Score (Higher scores = worse outcome). | Change from baseline in WOMAC® Total Score (Section A, B, and C, Items #1-24) as measured by VAS at Week 12. |
| WOMAC® Stiffness Subscore | To assess the change in the quality of life achieved by IA injection(s) of autologous BMAC compared to SOC in patients with knee OA. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Possible score range of 0-8 for Stiffness (Higher scores = worse outcome). | Change from Baseline in WOMAC® Stiffness Subscore (Section B, Items #6-7) as measured by VAS at Week 12 |
| SF-12 | 12-Item Short Form Survey (SF-12), The data calculate two summary component scores, Physical Component Summary Score (PCS) and Mental Health Component Summary Score (MCS) with eight sub-domains. Scores range from 0 to 100, where a zero score indicates the lowest level of health and 100 indicates the highest level of health, higher scores = better outcome. To assess the change in the quality of life achieved by IA injection(s) of autologous BMAC compared to SOC in patients with knee OA. | Change From Baseline in 12-Item Short-Form (SF-12) Health Survey (Quality of Life) Scores at Week 12. |
| Six Minute Walk Test | The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity, higher scores = better outcome To assess the change in the quality of life achieved by IA injection(s) of autologous BMAC compared to SOC in patients with knee OA. | Change from Baseline in the Six-Minute Walk Test at Week 12 |
| Exploratory - WOMAC® Pain Subscore |
To assess the change in the quality of life achieved by IA injection(s) of autologous BMAC compared to SOC in patients with knee OA. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Possible score range of 0-20 for Pain (Higher scores = worse outcome). |
| Change from baseline in WOMAC® Pain Subscore (Section A, Items #1-5) as measured by VAS at 24, 36, and 48-weeks |
| Exploratory - WOMAC® Physical Function Subscore | To assess the change in the quality of life achieved by IA injection(s) of autologous BMAC compared to SOC in patients with knee OA. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Possible score range of 0-68 for Physical (Higher scores = worse outcome). | Change from baseline in WOMAC® Physical Function Subscore (Section C, Items #8-24) as measured by VAS at 24, 36, and 48-weeks |
| Exploratory - WOMAC® Total Score | To assess the change in the quality of life achieved by IA injection(s) of autologous BMAC compared to SOC in patients with knee OA.The Western Ontario and McMaster Universities Arthritis Index (WOMAC) questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Possible score range of 0-96 for a Total Score (Higher scores = worse outcome). | Change from baseline in WOMAC® Total Score (Section A, B, and C, Items #1-24) as measured by VAS at 1, 4, 24, 36, and 48-weeks. |
| Exploratory - WOMAC® Stiffness Subscore | To assess the change in the quality of life achieved by IA injection(s) of autologous BMAC compared to SOC in patients with knee OA. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Possible score range of 0-8 for Stiffness (Higher scores = worse outcome). | Change from Baseline in WOMAC® Stiffness Subscore (Section B, Items #6-7) as measured by VAS at 1, 4, 24, 36, and 48-weeks. |
| Exploratory - SF-12 | To assess the change in the quality of life achieved by IA injection(s) of autologous BMAC compared to SOC in patients with knee OA. | Change From Baseline in 12-Item Short-Form (SF-12) Health Survey (Quality of Life) Scores at 4, 24, 36, and 48-weeks |