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

16 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to evaluate the effectiveness and safety of a permanent embolic (Embosphere Microspheres) for embolization of the geniculate artery for the treatment of moderate to severe knee osteoarthritis.

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 data supports the effectiveness of the treatment Embosphere Microspheres for knee osteoarthritis pain?

Research shows that using microspheres for embolization can help relieve pain in conditions like osteoarthritis and painful tumors. Studies comparing similar microspheres, like tris-acryl gelatin microspheres, suggest they can effectively block blood flow to reduce pain. ^{1 2 3 4 5}

Is Embosphere Microspheres treatment generally safe for humans?

Embosphere Microspheres have been used safely in humans for conditions like uterine fibroids and benign prostatic hyperplasia, showing good safety with mild side effects compared to other treatments. ^{1 2 6 7 8}

How is the treatment with Embosphere Microspheres different from other treatments for knee osteoarthritis pain?

Embosphere Microspheres are used in a procedure called embolization, where tiny particles are injected into blood vessels to block them, reducing pain by targeting the blood supply to areas causing discomfort. This approach is different from typical treatments like pain medications or physical therapy, as it directly addresses the blood vessels and nerves contributing to pain. ^{1 2 3 9 10}

Research Team

Felipe Ferreira De Souza

Principal Investigator

University of Miami

Eligibility Criteria

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 have a cancer diagnosis that is not non-melanoma skin cancer.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2023]

2. Japan pubmed.ncbi.nlm.nih.gov

Embolic effects of superabsorbent polymer microspheres in rabbit renal model: comparison with tris-acryl gelatin microspheres and polyvinyl alcohol. [2016]

3. Greece pubmed.ncbi.nlm.nih.gov

Clinical Utility of Bland Embolization Using Microspheres for Painful Malignant Musculoskeletal Tumors. [2023]

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

Genicular artEry embolizatioN in patiEnts with oSteoarthrItiS of the Knee (GENESIS) Using Permanent Microspheres: Interim Analysis. [2021]

5. China pubmed.ncbi.nlm.nih.gov

[Optimization and property evaluation of gelatin microspheres for embolization]. [2017]

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

Initial experience with use of tris-acryl gelatin microspheres for uterine artery embolization for leiomyomata. [2019]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Transplantation of Gelatin Microspheres Loaded with Wharton's Jelly Derived Mesenchymal Stem Cells Facilitates Cartilage Repair in Mice. [2023]

8. England 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. [2022]

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

Transcatheter arterial embolization as a treatment for medial knee pain in patients with mild to moderate osteoarthritis. [2015]

10. Ireland pubmed.ncbi.nlm.nih.gov

Gelatin microspheres: initial clinical experience for the transcatheter arterial embolization. [2008]