Bone Marrow Aspirate Concentrate (BMAC) Treatment for Knee Osteoarthritis

NCT06216028 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: CLL-001
• Study Type: interventional
• Target: 374
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis; Musculoskeletal Diseases

Keywords

Bone Marrow Aspirate Concentrate (BMAC); Bone Marrow Aspirate (BMA); Autologous; Phase 3; Randomized; Interventional

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (9)

• 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

  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

  Percentage of subjects classified as 'responders' as measured by improvement in WOMAC® Pain Subscore at Week 12

• WOMAC® Physical Function Subscore

  Percentage of subjects classified as 'responders' as measured by improvement in WOMAC® Physical Function Subscore 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.

Other Outcomes (6)

• Exploratory - Economic

  To determine the effect of IA injection(s) of autologous BMAC in promoting health economic outcomes, compared to controls

• Exploratory - WOMAC® Pain Subscore

  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

  Change from baseline in WOMAC® Physical Function Subscore (Section C, Items #8-24) as measured by VAS at 24, 36, and 48-weeks

Study Arms (2)

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)

Biological: Autologous Bone Marrow Aspirate Concentrate

Interventions

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)

Also known as: BMAC

Bone Marrow Aspirate Concentrate (BMAC)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Other conditions that may, according to medical criteria, discourage participation or impact outcome evaluation in the study.

Sponsors & Collaborators

• CELL Technologies Inc.: lead

Study Sites (1)

Canadian Centres for Regenerative Therapy (CCRT)

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Rheumatic Diseases

Study Officials

• Riam Shamma, MD

  CELL Technologies Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Riam Shammaa, MD

CONTACT

437-985-1505; info@celltechnologies.net

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: January 22, 2024
• Study Start: September 1, 2024
• Primary Completion: August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 24, 2024

Record last verified: 2024-05

Locations

CA (1)