Bone Marrow Cells for Knee Osteoarthritis

(ACCELERATE3 Trial)

Overseen By Riam Shammaa

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: CELL Technologies Inc.

Must not be taking: Oral anticoagulants, Heparin

Disqualifiers: Knee replacement, BMI ≥ 30, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

374 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but it does mention that treatments like low dose Aspirin and Plavix are allowed. If you are on oral anticoagulants or heparin therapy, you may not be eligible to participate.

What data supports the effectiveness of the treatment Bone Marrow Aspirate Concentrate (BMAC) for knee osteoarthritis?

Research shows that BMAC, which includes special cells called mesenchymal stem cells, is a promising treatment for knee osteoarthritis, with studies indicating it can help improve symptoms and function in affected patients. ^{1 2 3 4 5}

Is bone marrow aspirate concentrate (BMAC) safe for treating knee osteoarthritis?

Research on bone marrow aspirate concentrate (BMAC) for knee osteoarthritis suggests it is generally safe for use in humans, with studies focusing on its application for joint conditions. ^{2 3 6 7 8}

How is the treatment Bone Marrow Aspirate Concentrate (BMAC) unique for knee osteoarthritis?

Bone Marrow Aspirate Concentrate (BMAC) is unique for knee osteoarthritis because it involves injecting a concentrate of bone marrow cells directly into the knee joint, which provides growth factors that help reduce inflammation and promote tissue repair. Unlike other treatments, BMAC uses the body's own cells to potentially improve joint function and alleviate symptoms. ^{2 3 6 7 8}

What is the purpose of this 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.

Research Team

Riam Shamma, MD

Principal Investigator

CELL Technologies Inc.

Eligibility Criteria

This trial is for individuals with mild to severe knee osteoarthritis, which is a type of joint disease causing pain and stiffness. Participants will receive treatment in one or both knees.

Inclusion Criteria

Willing to provide written informed consent

Able to communicate satisfactorily with the investigator and comply with study requirements

I have been diagnosed with knee osteoarthritis, confirmed by X-rays.

Exclusion Criteria

I have had knee surgery within the last 6 months.

I have a condition that causes joint inflammation.

I have a significant knee deformity due to a disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intra-articular injection of autologous BMAC or Standard of Care

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 weeks

Multiple visits (in-person and virtual) for assessments and blood collection

Treatment Details

Interventions

• Bone Marrow Aspirate Concentrate (BMAC)

Trial Overview The ACCELERATE3 trial tests the effectiveness of a single injection of Bone Marrow Aspirate Concentrate (BMAC) compared to standard care injections in reducing knee arthritis symptoms.

Participant Groups

Group I: Bone Marrow Aspirate Concentrate (BMAC) Experimental Treatment 1 Intervention

Cell suspension for infusion. 50 mL of Bone Marrow Aspirate collected, and 10-15 mL BMAC injected to knee(s)

Group II: Standard of Care Active Control 1 Intervention

Standard of care IA injection may include cortisone or hyaluronic acid (HA) as per discretion of the Principal Investigator

Who Is Running the Clinical Trial?

CELL Technologies Inc.

Lead Sponsor

Trials

1

Recruited

370+

Findings from Research

In a study of 233 patients with knee osteoarthritis, a single intra-articular injection of bone marrow aspirate concentrate (BMAC) led to significant pain reduction, with the numeric pain scale decreasing from 8.33 to 4.49 after treatment.

The procedure was found to be safe, with no complications reported, and resulted in improved knee function as indicated by an increase in the Oxford knee score from 20.20 to 32.29 over an average follow-up period of 11 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a single intra-articular bone marrow aspirate concentrate (BMAC) injection in patients with grade 3 and 4 knee osteoarthritis. Themistocleous, GS., Chloros, GD., Kyrantzoulis, IM., et al.[2022]

Bone marrow aspirate concentrate (BMAC) injections significantly improve pain and patient-reported outcomes in knee osteoarthritis, with 94.4% of outcomes showing improvement over a mean follow-up of 12.9 months across 299 knees.

Despite its effectiveness, BMAC did not show clinical superiority over other treatments like platelet-rich plasma or microfragmented adipose tissue, and its high cost may limit its use compared to other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone Marrow Aspirate Concentrate for the Treatment of Knee Osteoarthritis: A Systematic Review. Keeling, LE., Belk, JW., Kraeutler, MJ., et al.[2022]

In a study of 55 patients with knee osteoarthritis, a single injection of autologous bone marrow aspirate concentrate (BMAC) led to significant improvements in patient-reported outcomes, including Tegner, VAS, and WOMAC scores.

The results suggest that BMAC is a beneficial and safe treatment option for knee osteoarthritis, as all measured outcomes showed statistically significant improvement from baseline to follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of bone marrow derived mesenchymal stem cells for the treatment of osteoarthritis: A retrospective long-term follow-up study. Mariani, C., Meneghetti, E., Zambon, D., et al.[2023]

Bone marrow aspirate concentrate (BMAC) injections show promise for treating osteoarthritis (OA), with 22 studies involving 4626 patients indicating overall safety and low adverse events.

Most studies reported improvements in pain and function, but significant variability in study quality and methodology suggests that more rigorous, large-scale trials are needed to confirm BMAC's effectiveness in OA treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone marrow concentrate injections for the treatment of osteoarthritis: evidence from preclinical findings to the clinical application. Cavallo, C., Boffa, A., Andriolo, L., et al.[2022]

Bone marrow aspirate concentrate (BMAC) shows potential for treating knee cartilage defects, with clinical studies indicating improved outcomes compared to traditional methods like microfracture, although the overall quality of these studies is low.

Animal studies have produced inconsistent results regarding the efficacy of BMAC, and the cells in BMAC do not meet the criteria for mesenchymal stem cells, suggesting that further research is needed to fully understand its mechanism and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Bone Marrow Aspirate Concentrate for the Treatment of Focal Chondral Lesions of the Knee: A Systematic Review and Critical Analysis of Animal and Clinical Studies. Cavinatto, L., Hinckel, BB., Tomlinson, RE., et al.[2020]

Bone marrow aspirate concentrate (BMAC) shows promising efficacy in treating chondral defects and osteoarthritis of the knee, with all studies reporting good to excellent outcomes.

The procedure is considered safe, but the review highlights a lack of high-quality studies, indicating a need for more rigorous research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concentrated Bone Marrow Aspirate for the Treatment of Chondral Injuries and Osteoarthritis of the Knee: A Systematic Review of Outcomes. Chahla, J., Dean, CS., Moatshe, G., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Short-Term Outcomes in Treatment of Knee Osteoarthritis With 4 Bone Marrow Concentrate Injections. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Effectiveness of a single intra-articular bone marrow aspirate concentrate (BMAC) injection in patients with grade 3 and 4 knee osteoarthritis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Bone Marrow Aspirate Concentrate for the Treatment of Knee Osteoarthritis: A Systematic Review. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy of autologous bone marrow concentrate for knee osteoarthritis with and without adipose graft. [2022]

5. India pubmed.ncbi.nlm.nih.gov

Use of bone marrow derived mesenchymal stem cells for the treatment of osteoarthritis: A retrospective long-term follow-up study. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Bone marrow concentrate injections for the treatment of osteoarthritis: evidence from preclinical findings to the clinical application. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The Role of Bone Marrow Aspirate Concentrate for the Treatment of Focal Chondral Lesions of the Knee: A Systematic Review and Critical Analysis of Animal and Clinical Studies. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Concentrated Bone Marrow Aspirate for the Treatment of Chondral Injuries and Osteoarthritis of the Knee: A Systematic Review of Outcomes. [2022]