Intra-articular Allocetra in Osteoarthritis of the 1st Carpo-metacarpal Joint
A Placebo-controlled Study of Intra-articular Allocetra in Osteoarthritis of the 1st Carpo-metacarpal Joint
Kaplan Medical Center
46 participants
Jun 10, 2024
INTERVENTIONAL
Conditions
Summary
This study is a single center trial to assess the safety and efficacy of intra-articular administration of Allocetra to patients with 1st CMC thumb joint osteoarthritis (OA).
Eligibility
Inclusion Criteria6
- 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.
Exclusion Criteria9
- Subjects not eligible for this study include those that have any of the following:
- 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.
- 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.
- Other limb pain of unknown etiology, or clinically significant widespread pain syndrome, e.g., fibromyalgia.
- 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.
- Bleeding disorders, cognitive disorder, neurologic disease or other major medical condition which may interfere with study participation, treatment, assessments, or results.
- For women of childbearing potential, a positive pregnancy test.
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Interventions
Intra-articular injection of Allocetra performed once on Day 1 of the study at different doses.
Intra-articular injection of placebo solution containing all excipients except for the Allocetra cells.
Intra-articular injection of selected dose of Allocetra based on the safety run-in, performed on Day 1 of the study.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06459063