SakuraBead Embolization for Osteoarthritis

(SURE Trial)

Recruiting at 8 trial locations

Overseen By Ari Isaacson, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: CrannMed

Disqualifiers: Severe knee OA, Autoimmune arthritis, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

89 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if genicular artery embolization (GAE) is more effective than standard corticosteroid injections for relieving knee osteoarthritis pain. People with moderate to severe knee pain that hasn't improved with treatments like physical therapy or anti-inflammatory drugs might be suitable candidates. The trial will compare the effectiveness of GAE, which temporarily blocks blood flow to specific knee arteries, with the traditional method of injecting steroids directly into the knee. As an unphased trial, it provides patients the chance to explore innovative treatments that could potentially enhance their quality of life.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves treatments for knee osteoarthritis, it's best to discuss your current medications with the trial team to ensure there are no conflicts.

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

Studies have shown that using SakuraBead resorbable microspheres for genicular artery embolization (GAE) is safe. In one study, patients experienced significant improvements in pain and movement after the procedure, with no major safety concerns reported. This suggests the treatment is well-tolerated.

Additionally, research on similar dissolvable materials used in these procedures has shown better safety and results. Early data from lab studies also support the safety of these microspheres. Although this treatment remains relatively new, the findings so far are promising for those considering it as an option. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Genicular Artery Embolization (GAE) for osteoarthritis because it offers a novel approach to pain management by temporarily blocking blood flow in the knee using resorbable microspheres. Unlike standard treatments like corticosteroid injections, which primarily focus on reducing inflammation, GAE targets the tiny blood vessels that contribute to joint pain. This distinct mechanism could potentially provide longer-lasting relief without the need for frequent medication doses.

What evidence suggests that this trial's treatments could be effective for osteoarthritis?

Studies have shown that SakuraBead genicular artery embolization (GAE), a treatment tested in this trial, can greatly reduce knee pain in people with osteoarthritis. Research using SakuraBead microspheres found that more than 75% of participants experienced less pain after six months. This treatment targets the blood vessels around the knee to relieve pain and improve movement. Early results suggest that the tiny, dissolvable beads used in this treatment are safe and effective. The aim is to provide long-lasting pain relief and improve the quality of life for those with knee osteoarthritis. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 40-80 with knee osteoarthritis (OA) who haven't found relief from pain after at least 3 months of anti-inflammatory drugs, physical therapy, or injections. Participants must be able to give consent and attend all treatments and follow-ups. They need confirmed OA evidence via specific angiographic patterns in the knee.

Inclusion Criteria

Able to comply with all treatments and follow-up visits

I am between 40 and 79 years old.

I experience moderate to severe knee pain.

Exclusion Criteria

I have a blood clotting disorder that cannot be corrected.

I have severe knee arthritis.

My affected joint is currently infected.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either SakuraBead genicular artery embolization or corticosteroid injection for knee osteoarthritis

6 months

Multiple visits for treatment and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 months

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Corticosteroid Injection
• SakuraBead Resorbable Microspheres

Trial Overview The study compares SakuraBead genicular artery embolization (GAE), a procedure that blocks certain blood vessels in the knee to reduce pain and inflammation, against corticosteroid injections which are commonly used for OA pain relief.

How Is the Trial Designed?

Group I: Genicular Artery Embolization (GAE) Experimental Treatment 1 Intervention

Temporary Embolization of Genicular Arteries using Resorbable Microspheres

Group II: Corticosteroid Injection Active Control 1 Intervention

Corticosteroid injection in the knee

Corticosteroid Injection is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Corticosteroid injection for:

• Acromioclavicular joint pain
• Shoulder impingement syndrome
• Rotator cuff disease
• Adhesive capsulitis
• Glenohumeral osteoarthritis

Approved in United States as Corticosteroid injection for:

• Acromioclavicular joint pain
• Shoulder impingement syndrome
• Rotator cuff disease
• Adhesive capsulitis
• Glenohumeral osteoarthritis

Approved in Canada as Corticosteroid injection for:

• Acromioclavicular joint pain
• Shoulder impingement syndrome
• Rotator cuff disease
• Adhesive capsulitis
• Glenohumeral osteoarthritis

Who Is Running the Clinical Trial?

CrannMed

Lead Sponsor

Trials

2

Recruited

100+

Published Research Related to This Trial

In a study involving 68 patients with knee osteoarthritis, long-term intraarticular steroid injections (triamcinolone acetonide) were found to be safe, showing no negative impact on joint structure over 2 years.

The steroid injections provided significant symptom relief, particularly in knee pain and stiffness, compared to saline injections, especially noted at the 1-year mark.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of long-term intraarticular steroid injections in osteoarthritis of the knee: a randomized, double-blind, placebo-controlled trial. Raynauld, JP., Buckland-Wright, C., Ward, R., et al.[2023]

Joint aspiration and injection are crucial for diagnosing and treating joint diseases, particularly in the knee, where synovial fluid can be obtained to diagnose conditions like septic and crystal arthritis.

Intra-articular injection of long-acting corticosteroids is effective for rapidly reducing inflammation in joints, is generally safe when performed with sterile techniques, and requires only basic anatomical knowledge, making it a common practice in rheumatology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Joint aspiration and injection. Courtney, P., Doherty, M.[2015]

In a study involving 12 patients with persistent buttock pain due to sacroiliitis, MR-guided corticosteroid injections into the sacroiliac joints led to significant clinical improvement, with a mean pain-free period of 9.6 months.

The dolorimetry scale showed a reduction in pain from an average of 7.6 to 2.9 after three months, allowing some patients to discontinue or reduce their use of nonsteroidal anti-inflammatory drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Corticosteroid injections of the sacroiliac joint during magnetic resonance: preliminary results]. Pereira, PL., Günaydin, I., Duda, SH., et al.[2013]

In a study of 199 participants with knee osteoarthritis, tenderness around the knee was linked to a better short-term response to intraarticular steroid injections, with 73.4% showing improvement within 2 weeks.

However, factors like chronic widespread pain and higher depression scores were associated with a lower likelihood of achieving long-term benefits from the treatment, indicating that psychological and broader pain conditions can impact treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do Clinical Correlates of Knee Osteoarthritis Predict Outcome of Intraarticular Steroid Injections? Maricar, N., Parkes, MJ., Callaghan, MJ., et al.[2023]

Corticosteroid injections, commonly used to reduce inflammation when other treatments fail, can have low incidence but notable sex-related side effects in female patients, including abnormal menstruation and lactation disturbances.

Orthopedic physicians should be aware of these specific side effects and communicate them to female patients during the informed consent process to ensure they are fully informed about potential risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Corticosteroid Injections: A Review of Sex-Related Side Effects. Brook, EM., Hu, CH., Kingston, KA., et al.[2022]

In a study of 3,822 patients with or at risk of knee osteoarthritis, those who received corticosteroid injections had a significantly higher risk of needing knee arthroplasty, with 31.3% undergoing surgery compared to only 5.0% of those who did not receive injections.

Each corticosteroid injection increased the absolute risk of knee arthroplasty by 9.4% over nine years, suggesting that these injections may harm the joint and accelerate the progression of osteoarthritis, leading to a recommendation for more conservative treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-articular corticosteroid injections increase the risk of requiring knee arthroplasty. Wijn, SRW., Rovers, MM., van Tienen, TG., et al.[2020]

Intra-articular corticosteroid injections for knee osteoarthritis showed a mild to moderate effect on pain severity lasting up to 3 months, which is longer than previously reported, based on a review of eight randomized controlled studies with follow-ups ranging from 1 to 26 weeks.

The risk of adverse effects from these injections was low, indicating that they are a relatively safe option for managing knee osteoarthritis pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Magnitude and Duration of the Effect of Intra-articular Corticosteroid Injections on Pain Severity in Knee Osteoarthritis: A Systematic Review and Meta-Analysis. Saltychev, M., Mattie, R., McCormick, Z., et al.[2021]

In a study involving 31 patients with spondylarthropathy, MR-guided corticosteroid injections into inflamed sacroiliac joints were found to be effective and safe, with no complications reported.

A second injection was beneficial for patients who did not respond to the first treatment, with 9 out of 15 showing improvement lasting an average of 16.1 months, indicating that repeated injections can provide additional relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging guided corticosteroid injection of sacroiliac joints in patients with spondylarthropathy. Are multiple injections more beneficial? Günaydin, I., Pereira, PL., Fritz, J., et al.[2018]

Corticosteroid injections are the most common treatment for osteoarthritis in the knee, but there is still debate among practitioners about their effectiveness and the best corticosteroid to use.

No consensus has been reached on the optimal corticosteroid type, dosage, or injection frequency, suggesting that treatment should be personalized based on individual patient needs and responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Corticosteroid injection into the osteoarthritic knee: drug selection, dose, and injection frequency. Douglas, RJ.[2012]

In a study of 1000 patients receiving intraarticular corticosteroid injections for hip and knee osteoarthritis, only 1% experienced severe complications, indicating a lower complication rate than previously reported in smaller studies.

The study found that women were disproportionately affected, accounting for 90% of the severe complications, which included osteonecrosis and insufficiency fractures, suggesting a need for further investigation into gender differences in response to these injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraarticular Steroid Injection in Hip and Knee with Fluoroscopic Guidance: Reassessing Safety. Graf, DN., Thallinger, A., Zubler, V., et al.[2022]

Citations

1. crannmed.com crannmed.com/for-physicians/

For Physicians The clinical investigation has demonstrated that SakuraBead resorbable microspheres are safe and statistically effective for use in arterial embolization ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06718478

First in Human Study of SakuraBead for Genicular Artery ... To evaluate safety and efficacy of SakuraBead for the treatment of pain secondary to knee osteoarthritis. Treatment will be performed on up to 15 patients who ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1051044325004725

First-in-Human Evaluation of a New Resorbable ... The primary endpoint was safety, with effectiveness evaluated as a secondary endpoint using the visual analog scale (VAS) pain score and the ...

4. app.trialscreen.org app.trialscreen.org/trials/phase-2-sakurabead-used-resorbable-embolic-genicular-artery-embolization-trial-nct06550024

SakuraBead Used as Resorbable Embolic for Genicular ... Benefits: Potential benefits of participating in this study include reduced knee pain and improved quality of life if the study treatment is effective.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12428030/

Single-Session Bilateral Genicular Artery Embolization for ... Similarly, an alginate-based resorbable microsphere (SakuraBead) demonstrated > 75% improvement in WOMAC pain scores at 6 months in a pilot ...

6. crannmed.com crannmed.com/sakurabead-pre-clinical-data-presented-at-gest-msk-2023/

SakuraBead pre-clinical data presented at GEST MSK 2023 We were encouraged to hear the strong message that resorbable embolics will improve safety and outcomes in Genicular Artery Embolization, as ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06550024?term=Skin+and+Connective+Tissue+Diseases

SakuraBead Used as Resorbable Embolic for Genicular ... To compare safety and efficacy of SakuraBead with corticosteroid injection for the treatment of pain secondary to knee osteoarthritis. Treatment will be ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11333116/

Genicular Artery Embolization Genicular artery embolization (GAE) has emerged as an effective minimally invasive therapy for managing medically refractory OA-related pain in ...