First in Human Study of SakuraBead for Genicular Artery Embolization to Treat Pain Secondary to Knee Osteoarthritis

A prospective, single-centre, single-arm, unmasked, First in Human study that aims to evaluate the safety and efficacy of SakuraBead resorbable microspheres in adult patients suffering from pain secondary to knee osteoarthritis.

Study Overview

• Status: Completed
• Conditions: Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis (OA) of the Knee; Osteoarthritis Knee Pain
• Intervention / Treatment: Device: SakuraBead Resorbable Microspheres

Detailed Description

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 will be followed up for a period of 6 months.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uzbekistan
  • Tashkent, Uzbekistan
    • The Republican Specialized Scientific and Practical Medical Center of Therapy and Medical Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patient is able and willing to provide written informed consent, and
2. Clinical diagnosis of knee OA, and
3. Moderate to severe knee pain (VAS ≥ 5), and
4. Pain refractory to at least 3 months* of conservative therapies (anti-inflammatory drugs, or physical therapy, or muscle strengthening, or intra-articular injections), and
5. Kellgren-Lawrence grade 1, 2 or 3 on radiograph of the knee, and
6. Age 40 years or older.
7. Subject has confirmed evidence of knee OA, defined as an angiographic 'blush' pattern (radiographic) in one or more of the target genicular artery(ies).

Exclusion Criteria:

1. Severe knee OA (Kellgren-Lawrence grade 4)
2. Current infection of target joint, or
3. Life expectancy less than 24 months, or
4. Known advanced atherosclerosis as defined by history of lower extremity or pelvis arterial bypass graft, lower extremity or pelvis arterial stent placement or prior history of vascular claudication, or
5. Rheumatoid or known serologic diagnosis of autoimmune arthritis, or
6. Prior knee replacement surgery in the target knee, or
7. Complete meniscal or cruciate tear that requires surgery, or
8. History of uncorrectable coagulopathy, or
9. Prior iodinated contrast reaction resulting in anaphylaxis, or
10. Pregnant and/or lactating female, or
11. At the discretion of the Principal Investigator
12. Subject has evidence of arterial occlusion precluding catheterization.
13. Subject has occlusion of the genicular arteries.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Genicular Artery Embolization (GAE); Temporary Embolization of Genicular Arteries using SakuraBead Resorbable Microspheres	Device: SakuraBead Resorbable Microspheres; Temporary Embolization of Genicular Arteries using SakuraBead Resorbable Microspheres

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Decrease of pain on Visual Analogue Scale (VAS) at 1 month follow-up.	1 month
Genicular Artery Embolization (GAE) without a major device- or procedure-related complication at 1 month follow-up	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
Reduction in global Western Ontario and McMaster University Osteoarthritis Index (WOMAC) questionnaire at 1 month, 3 months and 6 months follow-up	1, 3 and 6 months
Reduction of previously initiated OsteoArthritis (OA) medical therapy at 3- and 6-months follow-up	3 and 6 months
Decrease of pain on Visual Analogue Scale (VAS) at 3 and 6 months	3 and 6 months
No major device- or procedure-related complication at 3 and 6 months	3 and 6 months

Collaborators and Investigators

• Sponsor: CrannMed

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2023
• Primary Completion (Actual): March 28, 2024
• Study Completion (Actual): August 23, 2024

Study Registration Dates

• First Submitted: December 2, 2024
• First Submitted That Met QC Criteria: December 2, 2024
• First Posted (Estimated): December 5, 2024

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 2, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Knee Osteoarthritis; Knee OA; Genicular Artery Embolization; GAE; Knee Embolization
• Additional Relevant MeSH Terms: Arthritis; Connective Tissue Diseases; Joint Diseases; Osteoarthritis; Osteoarthritis, Knee; Musculoskeletal Diseases; Rheumatic Diseases; Collagen Diseases
• Other Study ID Numbers: CI520

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No