Embolization with Embosphere Microspheres for Knee Osteoarthritis Pain

Overseen By Lia Quezada

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Rheumatoid arthritis, Osteonecrosis, Active malignancy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 53

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of Embosphere Microspheres (tris-acryl gelatin microspheres) in easing pain from moderate to severe knee osteoarthritis. The goal is to determine if this treatment can safely reduce pain by blocking blood flow in a specific knee artery. Suitable participants have experienced persistent knee pain despite trying other treatments, such as medications or physical therapy, for at least 12 weeks and have tenderness in the front of their knee.

As an unphased trial, this study provides a unique opportunity for patients to explore a novel treatment option that could potentially alleviate their knee pain.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since it mentions a failed response to certain therapies, you might be able to continue them. It's best to discuss this with the trial team.

What prior data suggests that Embosphere Microspheres are safe for embolization in knee osteoarthritis?

Research has shown that Embosphere Microspheres offer a safe option for treating knee osteoarthritis. Studies indicate that this treatment remains safe and effective for up to two years post-procedure. Patients report good results and few safety issues over time.

In these studies, Embosphere Microspheres were used in a procedure called embolization, which blocks small blood vessels to help reduce knee pain. Importantly, no major safety concerns emerged in these studies, suggesting that patients tolerate it well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for knee osteoarthritis, like pain relievers or physical therapy, aim to manage symptoms without addressing the underlying issue. Embosphere Microspheres are unique because they work by embolizing small blood vessels in the knee, potentially reducing inflammation and pain at the source. This approach could offer longer-lasting relief by directly targeting the painful areas rather than just masking the symptoms. Researchers are excited about this treatment because it represents a novel method of providing relief for those with moderate to severe knee osteoarthritis, potentially improving patients' quality of life significantly.

What evidence suggests that Embosphere Microspheres might be an effective treatment for knee osteoarthritis?

Research shows that Embosphere Microspheres can help treat moderate to severe knee osteoarthritis pain. These tiny spheres are used in a procedure called embolization, which blocks blood flow to certain areas, greatly reducing pain and improving joint function. Data collected over two years confirms that this treatment is safe and effective. Participants in this trial will receive Embosphere Microspheres during their standard embolization surgery. Patients have experienced long-lasting relief from knee pain, making it a promising option for those with osteoarthritis. Overall, evidence suggests that Embosphere Microspheres can be a reliable choice for managing knee osteoarthritis symptoms. ^{1 2 3 4 5}

Who Is on the Research Team?

Felipe Ferreira De Souza

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for adults aged 40-80 with moderate to severe knee osteoarthritis who haven't improved after at least 12 weeks of standard treatments like NSAIDs, steroid injections, or physical therapy. Participants must have synovitis, be able to undergo an MRI, and not have advanced arthritis (Kellgren-Lawrence grade >3), prior knee replacement, certain health conditions that affect embolization procedures, allergies to contrast agents without prophylaxis options, active cancers (except skin cancer), local infections in the knee area or a sensitivity to gelatin.

Inclusion Criteria

Synovitis present as assessed by WORMS

My knee or hip pain is severe, based on a score above 30.

I have tried treatments like painkillers, injections, or physical therapy for my knee arthritis for at least 12 weeks without improvement.

Exclusion Criteria

My target knee is infected.

Kellgren-Lawrence grade >3

I am pregnant, breastfeeding, or planning to become pregnant soon.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Embosphere Microspheres during scheduled SOC embolization surgery for knee osteoarthritis

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

Multiple visits (in-person and virtual) over 52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Embosphere Microspheres

Trial Overview The study tests Embosphere Microspheres used in geniculate artery embolization as a treatment for pain from moderate to severe knee osteoarthritis. The goal is to see how effective and safe this permanent blockage procedure is compared to other treatments.

How Is the Trial Designed?

Group I: Embosphere Microspheres group Experimental Treatment 1 Intervention

Participants in this group who are receiving standard of care (SOC) embolization surgery for the treatment of moderate to severe knee osteoarthritis will receive the Embospheres Microspheres during scheduled SOC surgery.

Embosphere Microspheres is already approved in United States, European Union for the following indications:

Approved in United States as Embosphere Microspheres for:

• Uterine fibroid embolization

Approved in European Union as Embosphere Microspheres for:

• Uterine fibroid embolization

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Shivank Bhatia

Lead Sponsor

Trials

2

Recruited

20+

Published Research Related to This Trial

The study demonstrated that superabsorbent polymer microspheres (SAP-MS) effectively caused targeted kidney infarction in a rabbit model, showing distinct mechanical properties compared to polyvinyl alcohol (PVA) particles and tris-acryl gelatin microspheres (EM).

SAP-MS were able to conform to the vessel lumen and occlude blood flow more effectively than EM, indicating their potential for improved embolic therapy in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Embolic effects of superabsorbent polymer microspheres in rabbit renal model: comparison with tris-acryl gelatin microspheres and polyvinyl alcohol. Khankan, AA., Osuga, K., Hori, S., et al.[2016]

Bland embolization using microspheres provided effective pain relief for 90% of the 20 patients with painful malignant musculoskeletal tumors, indicating its efficacy in managing pain associated with these tumors.

The procedure was generally safe, with only 20% of patients experiencing grade-3 adverse events, and no severe complications (grade-4 or grade-5), suggesting it is a viable option for pain management in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Utility of Bland Embolization Using Microspheres for Painful Malignant Musculoskeletal Tumors. Taniguchi, J., Takaki, H., Kodama, H., et al.[2023]

Transcatheter arterial embolization was performed on 14 patients with mild to moderate knee osteoarthritis, resulting in significant pain relief as measured by the WOMAC pain scores, which improved from 12.2 to 3.3 at 1 month and further to 1.7 at 4 months.

The procedure was safe, with no major adverse events reported, and the improvements in pain and function were maintained for up to 19 months after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter arterial embolization as a treatment for medial knee pain in patients with mild to moderate osteoarthritis. Okuno, Y., Korchi, AM., Shinjo, T., et al.[2015]

The optimized gelatin microspheres, prepared using a specific emulsification crosslink method, demonstrated a degradable time of 2-3 weeks and appropriate elasticity, making them suitable for clinical use in embolization procedures.

The average diameter of the microspheres was 377.6 μm when dried and 535.6 μm when wet, with a significant water absorption rate achieved in 20 minutes and a swelling ratio of 41.9%, indicating effective performance characteristics for medical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Optimization and property evaluation of gelatin microspheres for embolization]. Wu, YN., Cui, DC., Liu, YY., et al.[2017]

Wharton's jelly-derived mesenchymal stem cells (WJMSCs) combined with gelatin microspheres (GMs) showed improved cell viability and enhanced chondrogenesis, making them a promising option for treating knee osteoarthritis (KOA).

In a mouse model of KOA, the transplantation of WJMSCs-GMs complexes led to significant cartilage regeneration and better joint structure, while GMs also increased the retention time of the stem cells in the knee joint, suggesting a potential strategy for effective stem cell therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transplantation of Gelatin Microspheres Loaded with Wharton's Jelly Derived Mesenchymal Stem Cells Facilitates Cartilage Repair in Mice. Chen, X., Huang, S., Niu, Y., et al.[2023]

Gelatin microspheres (GMSs) were successfully used in transcatheter arterial embolization (TAE) for five patients with tumors, demonstrating effective treatment of the targeted tumors.

Follow-up CT scans showed that the embolized tumors did not enhance, indicating successful embolization, and the GMSs passed easily through the microcatheter, highlighting their practical application in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gelatin microspheres: initial clinical experience for the transcatheter arterial embolization. Nitta, N., Ohta, S., Tanaka, T., et al.[2008]

In a Phase I study involving 30 patients, the use of tris-acryl gelatin microspheres for uterine artery embolization was technically successful in all cases, leading to significant improvements in menstrual bleeding and pelvic pain within three months.

The treatment was found to be safe, with only minor complications reported in nine patients and no major complications, indicating that this method could be a viable option for managing symptomatic leiomyomata.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial experience with use of tris-acryl gelatin microspheres for uterine artery embolization for leiomyomata. Spies, JB., Benenati, JF., Worthington-Kirsch, RL., et al.[2019]

In a study of 422 patients with prostatic hyperplasia, treatment with embosphere microspheres showed better safety and efficacy compared to gelatin sponge particles, with fewer adverse reactions and a lower chance of recurrent bleeding.

The use of embosphere microspheres resulted in less damage to prostatic function post-treatment, making it a favorable option for managing complications from prostatic hyperplasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Study on the Treatment of Benign Prostatic Hyperplasia by Embolization of Prostate Artery Based on Embosphere Microspheres and Gelatin Sponge Granules. Liu, J., Shi, D., Li, L., et al.[2022]

Genicular artery embolization (GAE) using quick-soluble gelatin sponge particles (QS-GSPs) achieved a 100% technical success rate in 97 procedures for treating chronic knee pain due to osteoarthritis in 71 patients.

The procedure resulted in a clinical success rate of 72% at 6 months, with significant pain reduction observed over time, and it was deemed safe with no major adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Safety and Effectiveness of Quick-Soluble Gelatin Sponge Particles for Genicular Artery Embolization for Chronic Knee Pain Associated with Osteoarthritis. Min, J., Park, SW., Hwang, JH., et al.[2023]

Genicular artery embolization (GAE) using permanent microspheres in 38 patients with mild to moderate knee osteoarthritis showed significant pain reduction, with mean visual analogue scale (VAS) scores improving from 60 at baseline to 36 at 3 months and 45 at 1 year.

The procedure was found to be safe, with only mild self-limiting adverse events reported, and significant improvements in knee MRI scores and patient-reported outcomes, indicating potential efficacy for managing knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genicular artEry embolizatioN in patiEnts with oSteoarthrItiS of the Knee (GENESIS) Using Permanent Microspheres: Interim Analysis. Little, MW., Gibson, M., Briggs, J., et al.[2021]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0968016022002186

Two-year outcomes comparing Embosphere ... Embosphere Microspheres can be considered a safe and effective embolic agent for GAE for treating moderate to severe knee osteoarthritis with sustained outcomes ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36608360/

Two-year outcomes comparing Embosphere® ... This study compares the efficacy and safety of trisacryl gelatin microspheres to Imipenem/Cilastatin particles for GAE with 2 years of clinical follow-up.

3. thekneejournal.com thekneejournal.com/article/S0968-0160(22)00218-6/abstract

Two-year outcomes comparing Embosphere ... This study compares the efficacy and safety of trisacryl gelatin microspheres to Imipenem/Cilastatin particles for GAE with 2 years of clinical ...

4. clinicaltrial.be clinicaltrial.be/en/details/18968?per_page=100&recruiting=1&enrolling_by_invitation=0&active_not_recruiting=0&not_yet_recruiting=0&completed=0&only_recruiting=1&only_eligible=0

Effectiveness and Safety of Embosphere Microspheres for E... The purpose of this research study is to evaluate the effectiveness and safety of a permanent embolic (Embosphere Microspheres) for embolization ...

5. trials.arthritis.org trials.arthritis.org/trials/NCT05112926

Effectiveness and Safety of Embosphere Microspheres for ... The purpose of this research study is to evaluate the effectiveness and safety of a permanent embolic (Embosphere Microspheres) for embolization of the ...