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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for knee osteoarthritis using bone marrow cells. It aims to determine if a single injection of Bone Marrow Aspirate Concentrate (BMAC) is more effective than standard treatments such as cortisone or hyaluronic acid injections. Individuals with knee osteoarthritis that hasn't improved with pain medications or other treatments, and who have experienced persistent knee pain for at least three months, might be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to the development of a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Bone Marrow Aspirate Concentrate (BMAC) is generally safe for treating knee osteoarthritis. One study found that 95% of patients experienced complete pain relief after a year and improved mobility. Another study reported that BMAC injections were safe and effective for about 63% of patients with early knee osteoarthritis. These findings suggest that BMAC is well-tolerated and could be a promising option for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for knee osteoarthritis?

Researchers are excited about Bone Marrow Aspirate Concentrate (BMAC) for knee osteoarthritis because it offers a regenerative approach that differs from standard treatments like cortisone or hyaluronic acid injections. BMAC is derived from a patient's own bone marrow and contains stem cells that can potentially repair damaged tissues in the knee, rather than just alleviating symptoms. This treatment aims to address the root cause of osteoarthritis by promoting natural healing and tissue regeneration, offering hope for more sustained relief compared to conventional methods.

What evidence suggests that Bone Marrow Aspirate Concentrate (BMAC) might be an effective treatment for knee osteoarthritis?

Research has shown that Bone Marrow Aspirate Concentrate (BMAC), which participants in this trial may receive, could be a promising treatment for knee osteoarthritis (OA). In one study, 95% of patients experienced complete pain relief a year after receiving BMAC, and their knee function improved. Another study found that symptoms like pain and stiffness improved significantly over four years. BMAC also appears more effective than hyaluronic acid injections, which are part of the standard care treatment arm in this trial. Overall, these studies suggest that BMAC could be a strong option for reducing pain and improving movement in people with knee OA. ^{1 3 6 7 8}

Who Is on the Research Team?

Riam Shamma, MD

Principal Investigator

CELL Technologies Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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) 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 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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38929594/

Effectiveness and Complications of Bone Marrow Aspirate ... This study retrospectively evaluated data from 231 patients (285 knees) with knee OA treated with BMAC articular injection at a single center ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12113016/

Bone Marrow Aspirate Concentrate (BMAC) for Knee ... [24] found that 95% of patients achieved complete pain relief after one year of BMAC treatment, with significant improvements in functional outcomes (p < 0.0001) ...

3. nature.com nature.com/articles/s41598-024-51410-2

Intra-articular injection of bone marrow aspirate ... This is the first study on BMAC injections into 37 osteoarthritic knees with a 4-year follow up showing significant improvements in IKDC and WOMAC scores.

4. mayoclinic.org mayoclinic.org/medical-professionals/physical-medicine-rehabilitation/news/analyzing-the-performance-of-platelet-rich-plasma-and-bone-marrow-aspirate-concentrate-injections-for-the-treatment-of-knee-osteoarthritis/mqc-20578651

Analyzing the performance of platelet-rich plasma and ... Many of our patients with knee OA report from 6 to 12 months of pain relief after treatment with PRP. We usually see a 60% to 70% chance of success.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749806323002207

Patients With Knee Osteoarthritis Who Receive Platelet ... The most important findings from this systematic review were consistently better results with PRP and BMAC compared with HA injections for patients with knee OA ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11206007/

Effectiveness and Complications of Bone Marrow Aspirate ... Our study reports the most important result that the use of BMAC to treat patients with K–L grades II–III knee OA is effective, but ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1934148218302880

Early Clinical Outcomes of Intra-Articular Injections of Bone ... Intra-articular injections of BMC for the treatment of early knee or hip OA were safe and demonstrated satisfactory results in 63.2% of patients. Future studies ...

8. biologicortho.com biologicortho.com/index.php/BiologicOrtho/article/view/71

A REVIEW OF BONE MARROW ASPIRATE ... Eight hundred seventy-six patients were injected with BMAC and 1,010 knees with osteoarthritis were included in this literature review. For studies that passed ...