Allocetra - Safety run-in phase: Intra-articular injection of Allocetra performed once on Day 1 of the study at different doses.
Placebo: Intra-articular injection of placebo solution containing all excipients except for the Allocetra cells.
Allocetra - Randomization phase: Intra-articular injection of selected dose of Allocetra based on the safety run-in, performed on Day 1 of the study.
Study 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
Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
Subjects eligible for this clinical study must fulfill all of the following:
1. Age 40 years or older.
2. 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.
3. Score of 6 or higher on the Functional Index for Hand Osteoarthritis (FIHOA).
4. X-ray confirming OA of the first CMC joint of the target thumb with a Grade of 2 or 3 according to Eaton classification.
5. Blood tests from up to three months before treatment within protocol-defined limits.
Exclusion Criteria:
Subjects not eligible for this study include those that have any of the following:
1. 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.
2. History of chondrocalcinosis in the target joint, concomitant rheumatic disease.
3. Previous intra-articular injection of steroid, hyaluronate, or other agent, into the target joint within 3 months prior to screening visit.
4. Other limb pain of unknown etiology, or clinically significant widespread pain syndrome, e.g., fibromyalgia.
5. Pain in the limb clinically assessed to arise from an origin which is not the affected thumb joint (wrist pain, shoulder pain, etc.).
6. Secondary OA such as gout, hemochromatosis, rheumatoid/psoriatic arthritis.
7. Bleeding disorders, cognitive disorder, neurologic disease or other major medical condition which may interfere with study participation, treatment, assessments, or results.
8. For women of childbearing potential, a positive pregnancy test.
Primary outcome measure(s)
Injection-related reactions — Day 0 (Treatment visit). Injection-related reactions occurring during study treatment injection, including injection interruption/discontinuation.
Treatment emergent adverse events — Day 0 to 6 months. Treatment emergent adverse events following study treatment injection. Safety assessments beyond 4 weeks following injection will focus on events that are at least possibly related to study treatment.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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