Phase
Condition
Osteoarthritis
Connective Tissue Diseases
Lupus
Treatment
Corticosteroid Injection
SakuraBead Resorbable Microspheres
Clinical Study ID
Ages 40-79 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject is able and willing to provide written informed consent, and
Clinical diagnosis of knee OA, and
Moderate to severe knee pain (WOMAC Pain ≥ 10), and
Pain refractory to at least 3 months of conservative therapies (anti-inflammatorydrugs, or physical therapy, or intra-articular injections), and
Kellgren-Lawrence grade 1, 2 or 3 on radiograph of the knee, and
Age ≥ 40 years and < 80 years, and
Able to comply with all treatments and follow-up visits.
Exclusion
Exclusion Criteria:
Severe knee OA (Kellgren-Lawrence grade 4), or
Current infection of target joint, or
Life expectancy less than 36 months, or
Known advanced atherosclerosis as defined by history of lower extremity or pelvisarterial bypass graft, lower extremity or pelvis arterial stent placement or priorhistory of vascular claudication, or
Rheumatoid or known serologic diagnosis of autoimmune arthritis, or
Prior knee replacement surgery in the target knee, or
Pain score of >3 NRS on the non-target knee, or
An acute internal derangement of the target knee, or
History of uncorrectable coagulopathy, or
Prior iodinated contrast reaction resulting in anaphylaxis, or
Active pregnancy as demonstrated by urine or serum β-hCG, or lactating female, orplanning pregnancy in the following 12 months, or
Has undergone an invasive treatment (including but not limited to: corticosteroidinjection, hyaluronic acid injections, nerve ablation) in the target knee within thepast 3 months, or
Contraindication to MRI, or
At the discretion of the Principal Investigator
Study Design
Study Description
Connect with a study center
Bokhua Memorial Cardiovascular Center
Tbilisi,
GeorgiaSite Not Available
Bokhua Memorial Cardiovascular Center
Tbilisi 611717,
GeorgiaSite Not Available
Royal Berkshire NHS Foundation Trust
Reading, RG1 5AN
United KingdomSite Not Available
Royal Berkshire NHS Foundation Trust
Reading 2639577, RG1 5AN
United KingdomSite Not Available
University of Alabama Medicine
Birmingham, Alabama 35233
United StatesSite Not Available
University of Alabama Medicine
Birmingham 4049979, Alabama 4829764 35233
United StatesSite Not Available
Harbor UCLA Medical Center
Torrance, California 90502
United StatesSite Not Available
Harbor UCLA Medical Center
Torrance 5403022, California 5332921 90502
United StatesSite Not Available
Advanced Vascular Institute
Panama City, Florida 32405
United StatesSite Not Available
Advanced Vascular Institute
Panama City 4167694, Florida 4155751 32405
United StatesSite Not Available
IR Centers
Raleigh, North Carolina 27617
United StatesSite Not Available
IR Centers
Raleigh 4487042, North Carolina 4482348 27617
United StatesSite Not Available
Orthopedic and Fracture Specialists (O&FS)
Beaverton, Oregon 97007
United StatesSite Not Available
Orthopedic and Fracture Specialists (O&FS)
Portland, Oregon 97225
United StatesSite Not Available
Orthopedic and Fracture Specialists (O&FS)
Portland 5746545, Oregon 5744337 97225
United StatesSite Not Available
IR Centers
Leesburg, Virginia 20176
United StatesSite Not Available
IR Centers
Leesburg 4769125, Virginia 6254928 20176
United StatesSite Not Available
Nano Medical Clinic
Tashkent, Uzbekistan 100095
UzbekistanSite Not Available
Nano Medical Clinic
Tashkent 1512569, Uzbekistan 100095
UzbekistanSite Not Available

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