Intra-articular Allocetra in Osteoarthritis of the 1st Carpo-metacarpal Joint (NCT06459063) | Clinical Trial Compass
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 range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.