Bone Marrow Aspirate ConCentrate for the Treatment of knEe Osteoarthritis: A Phase III, muLti-centER, Pan-cAnadian, prospecTivE Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 374
- 试验地点
- 1
- 主要终点
- WOMAC® Pain Subscore
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
Standard of Care
Standard of care IA injection may include cortisone or hyaluronic acid (HA) as per discretion of the Principal Investigator
Bone Marrow Aspirate Concentrate (BMAC)
Cell suspension for infusion. 50 mL of Bone Marrow Aspirate collected, and 10-15 mL BMAC injected to knee(s)
干预措施: Autologous Bone Marrow Aspirate Concentrate (Biological)
结局指标
主要结局
WOMAC® Pain Subscore
时间窗: 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).
次要结局
- WOMAC® Pain Subscore(Percentage of subjects classified as 'responders' as measured by improvement in WOMAC® Pain Subscore at Week 12)
- WOMAC® Stiffness Subscore(Change from Baseline in WOMAC® Stiffness Subscore (Section B, Items #6-7) as measured by VAS at Week 12)
- WOMAC® Total Score(Change from baseline in WOMAC® Total Score (Section A, B, and C, Items #1-24) as measured by VAS at Week 12.)
- Safety (Baseline to Day 30 post IA injection)(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(Percentage of subjects classified as 'responders' as measured by improvement in WOMAC® Physical Function Subscore at Week 12)
- SF-12(Change From Baseline in 12-Item Short-Form (SF-12) Health Survey (Quality of Life) Scores at Week 12.)
- WOMAC® Physical Function and Pain Subscore(Percentage of subjects classified as 'responders' as measured by a composite responder analysis at Week 12.)
- Six Minute Walk Test(Change from Baseline in the Six-Minute Walk Test at Week 12)
- WOMAC® Physical Function Subscore(Change in WOMAC® Physical Function Subscore (Section C, Items #8-24) as measured by VAS from Baseline to the end of Week 12.)