Knee OsteoarthritisPhase 3ACCELERATE3NCT06216028
Bone Marrow Aspirate Concentrate (BMAC) Treatment for Knee Osteoarthritis
A Phase 3 study testing Autologous Bone Marrow Aspirate Concentrate in people with Knee Osteoarthritis and Musculoskeletal Diseases, run by CELL Technologies Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis, Musculoskeletal Diseases
- What is being tested?
- Autologous Bone Marrow Aspirate Concentrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 374 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2024to Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- Subjects who have knee replacement surgery planned within 6 months of enrollment.
- Subjects with a BMI ≥ 30kg/m2
- Prior Partial Joint Replacement (PJR) or Total Joint Replacement (TJR) of one or both knees.
- Knee surgery in the previous 6 months prior to enrollment.
- Concomitant inflammatory disease or other condition affecting the joints (e.g., rheumatoid arthritis, septic arthritis, inflammatory joint disease, metabolic bone disease, psoriasis, gout, microcrystalline arthropathies/chondrocalcinosis, Paget's disease).
- Congenital or acquired diseases leading to significant knee deformities that may interfere with cell application or the interpretation of results.
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- Instances of widespread pain or any pain that could interfere with the assessment of index knee pain (e.g. pain in any other part of the lower extremities, pain radiating to the knee).
- Signs of active uncontrolled infection or known history of HIV, hepatitis, or syphilis.
- A diagnosis of any form of cancer in the previous 6 months.
- Actively treated with oral anticoagulants or heparin therapy (treatment such as low dose Aspirin and Plavix are allowed).
- Participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study.
- Other conditions that may, according to medical criteria, discourage participation or impact outcome evaluation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Canadian Centres for Regenerative Therapy (CCRT)
Toronto, Ontario
Riam Shammaa
About this study
Official title: Bone Marrow Aspirate ConCentrate for the Treatment of knEe Osteoarthritis: A Phase III, muLti-centER, Pan-cAnadian, prospecTivE Trial
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.
Read the 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
- Being tested
- Autologous Bone Marrow Aspirate Concentrate
- Keywords
- Bone Marrow Aspirate Concentrate (BMAC), Bone Marrow Aspirate (BMA), Autologous, Phase 3, Randomized, Interventional
- Medical subject headings
- Osteoarthritis, Knee, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Bone Marrow Aspirate ConcentrateBiological
Also called BMAC
Range of between 18.7 X 104 cells/mL and 21.8 X 106 cells/mL total nucleated cells (TNC)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Biological: Autologous Bone Marrow Aspirate Concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change in WOMAC® Pain Subscore (Section A, Items #1-5) as measured by VAS from Baseline to the end of Week 12.
Secondary outcomes (9)
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.
Measured: 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)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Change from Baseline in the Six-Minute Walk Test at Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study startSep 2024 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 374 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CELL Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Riam Shamma, MD, Principal investigator, CELL Technologies Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216028
- Sponsor's protocol ID
- CLL-001
- Acronym
- ACCELERATE3
- Status last verified
- May 2024
- First submitted
- 14 Dec 2023
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Marrow Aspirate ConCentrate for the Treatment of knEe Osteoarthritis: A Phase III, muLti-centER, Pan-cAnadian, prospecTivE Trial
- ClinicalTrials.gov ID
- NCT06216028
- Acronym / sponsor ID
- ACCELERATE3 / CLL-001
- Conditions
- Knee Osteoarthritis, Musculoskeletal Diseases
- Keywords
- Bone Marrow Aspirate Concentrate (BMAC), Bone Marrow Aspirate (BMA), Autologous, Phase 3, Randomized, Interventional
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 374 participants (estimated)
- Lead sponsor
- CELL Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2024 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Biological: Autologous Bone Marrow Aspirate ConcentrateCell suspension for infusion. 50 mL of Bone Marrow Aspirate collected, and 10-15 mL BMAC injected to knee(s) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- Subjects who have knee replacement surgery planned within 6 months of enrollment.
- Subjects with a BMI ≥ 30kg/m2
- Prior Partial Joint Replacement (PJR) or Total Joint Replacement (TJR) of one or both knees.
- Knee surgery in the previous 6 months prior to enrollment.
- Concomitant inflammatory disease or other condition affecting the joints (e.g., rheumatoid arthritis, septic arthritis, inflammatory joint disease, metabolic bone disease, psoriasis, gout, microcrystalline arthropathies/chondrocalcinosis, Paget's disease).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Bone Marrow Aspirate ConcentrateAlso: BMACRange of between 18.7 X 104 cells/mL and 21.8 X 106 cells/mL total nucleated cells (TNC) | Biological | Bone Marrow Aspirate Concentrate (BMAC) |
Primary outcome
WOMAC® Pain Subscore
Time frame: Change in WOMAC® Pain Subscore (Section A, Items #1-5) as measured by VAS from Baseline to the end of Week 12.
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).
9 secondary outcomes
Safety (Baseline to Day 30 post IA injection)
Time frame: 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)
WOMAC® Physical Function Subscore
Time frame: 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
Time frame: Percentage of subjects classified as 'responders' as measured by improvement in WOMAC® Pain Subscore at Week 12
WOMAC® Physical Function Subscore
Time frame: Percentage of subjects classified as 'responders' as measured by improvement in WOMAC® Physical Function Subscore at Week 12
WOMAC® Physical Function and Pain Subscore
Time frame: Percentage of subjects classified as 'responders' as measured by a composite responder analysis at Week 12.
WOMAC® Total Score
Time frame: 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
Time frame: Change from Baseline in WOMAC® Stiffness Subscore (Section B, Items #6-7) as measured by VAS at Week 12
SF-12
Time frame: Change From Baseline in 12-Item Short-Form (SF-12) Health Survey (Quality of Life) Scores at Week 12.
Six Minute Walk Test
Time frame: Change from Baseline in the Six-Minute Walk Test at Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Riam Shamma, MD principal investigator
CELL Technologies Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Autologous Bone Marrow Aspirate Concentrate in people with Knee Osteoarthritis and Musculoskeletal Diseases, run by CELL Technologies Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Riam Shammaa, MD (437-985-1505, info@celltechnologies.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC® Pain Subscore (time frame: Change in WOMAC® Pain Subscore (Section A, Items #1-5) as measured by VAS from Baseline to the end of Week 12.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.