SakuraBead for Genicular Artery Embolization (SURE)
Research type
Research Study
Full title
SakuraBead used as Resorbable Embolic for Genicular Artery Embolization (SURE)
IRAS ID
353046
Contact name
Joan McCabe
Contact email
Sponsor organisation
CrannMed US Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 7 months, 29 days
Research summary
SakuraBead is a new medical device designed for patients with knee osteoarthritis. Knee osteoarthritis (OA) is a common progressive multifactorial joint disease characterised by chronic pain and functional disability, accounting for almost four fifths of the burden of OA worldwide and increases with obesity and age. Treatment for knee osteoarthritis is broad, including exercise; pharmacologic therapies (oral, topical, and intra-articular medications) and surgical interventions, including total joint arthroplasty. Presently, there is no cure for knee OA except for knee arthroplasty, which is considered an effective treatment at an advanced stage of the disease but is responsible for substantial health costs. The principal symptom of OA pain is mediated by several factors. Angiogenesis resulting in neovascularity, neural sensitization and inflammation has been described as a potential pathophysiological pathway of the deep joint pain described by many OA subjects. This increased vascularity in the setting of pain and OA has been the focus of recent endovascular investigations, with the proposed mechanism of embolisation (blocking blood vessels) as a novel treatment. Clinical studies have demonstrated that inflammation and chronic pain associated with osteoarthritis is disrupted by embolisation of the microvessels of the synovium. Targeted delivery of microspheres into the genicular arteries alleviates knee swelling (synovitis) and provides subjects with the benefit of significant pain reduction following treatment. CrannMed has developed SakuraBead embolisation microspheres to treat the pain associated with knee osteoarthritis by embolising the neovasculature attributed to this pain. Because there is a potential long-term risk of having any permanent blockage in the blood vessels of the knee, CrannMed has designed SakuraBead to breakdown after the mode of action (temporary arrest of blood flow to the neovessels) is complete. This open label, prospective, two-arm, parallel, multicentre, randomised controlled trial will compare SakuraBead genicular artery embolisation (GAE) with a control (corticosteroid injection) in patients with pain secondary to knee OA and who have been resistant to conservative therapy for at least 3 months.
REC name
London - Dulwich Research Ethics Committee
REC reference
25/LO/0264
Date of REC Opinion
13 May 2025
REC opinion
Further Information Favourable Opinion