Active, not recruitingPhase 1/2
Intra-articular Allocetra in Osteoarthritis of the 1st Carpo-metacarpal Joint
Key facts
- Who runs it
- Kaplan Medical Center
- Where
- Israel1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- Phase
- Phase 1/2
- People taking part
- 46 people, planned
- Started
- 10 Jun 2024
- Expected to end
- Jan 2027
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Allocetra - Safety run-in phase
- Placebo
- Allocetra - Randomization phase
- Record updated
- 13 April 2026
Who can take part
- Age
- 40 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
- Other limb pain of unknown etiology, or clinically significant widespread pain syndrome, e.g., fibromyalgia
- Bleeding disorders, cognitive disorder, neurologic disease or other major medical condition which may interfere with study participation, treatment, assessments, or results
- Subjects not eligible for this study include those that have any of the following:
- 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
- For women of childbearing potential, a positive pregnancy test
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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).
The 3 groups in the trial
- Safety run-in phase - Allocetra increasing doseOther group
A dose escalation phase to characterize the safety of Allocetra injection to the 1st CMC joint in the target thumb in different doses and select the dose for the randomized phase.
Treatment: Allocetra - Safety run-in phase
- Randomization phase - AllocetraExisting treatment, for comparison
Injection of Allocetra to the 1st CMC joint in the target thumb.
Treatment: Allocetra - Randomization phase
- Randomization phase - PlaceboPlacebo, for comparison
Injection of placebo to the 1st CMC joint in the target thumb.
Treatment: Placebo
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Placebo-controlled Study of Intra-articular Allocetra in Osteoarthritis of the 1st Carpo-metacarpal Joint
- Record updated
- 13 April 2026