Using Allocetra to treat thumb osteoarthritis

A Placebo-controlled Study of Intra-articular Allocetra in Osteoarthritis of the 1st Carpo-metacarpal Joint

This study is testing if Allocetra, a new cell-based treatment, can help people with thumb osteoarthritis who haven't found relief from other therapies.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Kaplan Medical Center (other)
• Locations: 1 site (Rehovot)
• Trial ID: NCT06459063 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of Allocetra, an immunomodulatory cell-based therapy, administered directly into the first carpometacarpal joint of patients suffering from osteoarthritis of the thumb. The study includes a safety run-in phase to determine the safety of different doses of Allocetra, followed by a placebo-controlled, double-blind randomized phase to assess its effectiveness. Participants will be monitored for up to one year after treatment to evaluate outcomes related to pain and function. The trial specifically targets patients who have not responded adequately to conventional therapies.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 40 and older with confirmed osteoarthritis of the first CMC joint who have not found relief from standard treatments.

Not a fit: Patients with significant injuries, infections, or other conditions affecting the target hand may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide significant pain relief and improved function for patients with thumb osteoarthritis who have exhausted other options.

How similar studies have performed: While the use of cell-based therapies in osteoarthritis is an emerging field, similar approaches have shown promise in other joint conditions, suggesting potential for success in this trial.

Eligibility criteria

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.

Where this trial is running

Rehovot

• Kaplan Medical Center — Rehovot, Israel (RECRUITING)

Study contacts

• Study coordinator: Amir Oron, MD

Conditions: Osteoarthritis Thumb, Allocetra, Cell therapy, Carpo-metacarpal, Osteoarthritis, Thumb, Macrophage