Active — Not RecruitingPhase 1/2

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

Israel46 participantsStarted 2024-06-10

Plain-language 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).

Who can participate

Age range40 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Injection-related reactions

Timeframe: Day 0 (Treatment visit).

Treatment emergent adverse events

Timeframe: Day 0 to 6 months.

Trial details

NCT IDNCT06459063

SponsorKaplan Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09

View on ClinicalTrials.gov More Osteoarthritis Thumb trials