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Clinical Trials in Israel / NCT06459063
Active, not recruiting Phase 1/2

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

NCT06459063 · tracked via the Priya Life Science Israel tracker
Phase
Phase 1/2
Started
2024-06-10
Last updated
2026-04-13

Condition(s) studied

Osteoarthritis Thumb

Investigational drug(s) / intervention(s)

Allocetra - Safety run-in phasePlaceboAllocetra - Randomization phase

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)

Trial sites (1)

FacilityCityRegionStatus
Kaplan Medical Center Rehovot Israel

More Kaplan Medical Center trials in Israel

Official registry record

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.

View NCT06459063 on ClinicalTrials.gov ↗ ← All trials in Israel