Bone Marrow Aspirate Concentrate (BMAC) Treatment for Knee Osteoarthritis

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Биопрепарат 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)

Первичные конечные точки

• WOMAC® Pain Subscore [Срок оценки: Change in WOMAC® Pain Subscore (Section A, Items #1-5) as measured by VAS from Baseline to the end of Week 12.]

Вторичные конечные точки (9)

• Safety (Baseline to Day 30 post IA injection) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Percentage of subjects classified as 'responders' as measured by improvement in WOMAC® Pain Subscore at Week 12]
• WOMAC® Physical Function Subscore [Срок оценки: Percentage of subjects classified as 'responders' as measured by improvement in WOMAC® Physical Function Subscore at Week 12]
• WOMAC® Physical Function and Pain Subscore [Срок оценки: Percentage of subjects classified as 'responders' as measured by a composite responder analysis at Week 12.]
• WOMAC® Total Score [Срок оценки: 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 [Срок оценки: Change from Baseline in WOMAC® Stiffness Subscore (Section B, Items #6-7) as measured by VAS at Week 12]
• SF-12 [Срок оценки: Change From Baseline in 12-Item Short-Form (SF-12) Health Survey (Quality of Life) Scores at Week 12.]
• Six Minute Walk Test [Срок оценки: Change from Baseline in the Six-Minute Walk Test at Week 12]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Canadian Centres for Regenerative Therapy (CCRT) — Toronto

Идентификаторы

NCT: NCT06216028 · CLL-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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