Intra-articular Allocetra in Osteoarthritis of the 1st Carpo-metacarpal Joint

Ki vehet részt

• Subjects eligible for this clinical study must fulfill all of the following:
• Age 40 years or older
• Patients with OA of the first CMC joint of the target thumb (basal thumb joint) who have failed conventional therapies, with pain assessed when not taking analgesic medications
• Score of 6 or higher on the Functional Index for Hand Osteoarthritis (FIHOA)
• X-ray confirming OA of the first CMC joint of the target thumb with a Grade of 2 or 3 according to Eaton classification
• Blood tests from up to three months before treatment within protocol-defined limits

Ki nem vehet részt

• History of chondrocalcinosis in the target joint, concomitant rheumatic disease
• Previous intra-articular injection of steroid, hyaluronate, or other agent, into the target joint within 3 months prior to screening visit
• Any significant injury, fracture, surgery, active local infection, deformity, severe Carpal Tunnel Syndrome (CTS), DeQuervain's tenosynovitis, trigger finger, or a ganglion cyst of the target hand
• Other limb pain of unknown etiology, or clinically significant widespread pain syndrome, e.g., fibromyalgia
• Bleeding disorders, cognitive disorder, neurologic disease or other major medical condition which may interfere with study participation, treatment, assessments, or results
• Subjects not eligible for this study include those that have any of the following:
• Pain in the limb clinically assessed to arise from an origin which is not the affected thumb joint (wrist pain, shoulder pain, etc.)
• Secondary OA such as gout, hemochromatosis, rheumatoid/psoriatic arthritis
• For women of childbearing potential, a positive pregnancy test