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

CrannMed

Status: Completed

Conditions: Osteoarthritis; Joint Diseases; Arthritis; Musculoskeletal Diseases; Osteoarthritis Knee Pain; Osteoarthritis (OA) of the Knee; Rheumatic Diseases

Treatments: Device: SakuraBead Resorbable Microspheres

Study type: Interventional

Funder types: Industry

Identifiers

NCT06718478

CI520

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Genicular Artery Embolization (GAE)

Experimental group

Description:

Temporary Embolization of Genicular Arteries using SakuraBead Resorbable Microspheres

Treatment:

Device: SakuraBead Resorbable Microspheres