A Phase 1/2 interventional study of Allocetra - Safety run-in phase and Placebo in Osteoarthritis Thumb, sponsored by Kaplan Medical Center. Active, not recruiting at 1 site in Israel. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Kaplan Medical Center · Phase 1/2, Interventional, and Treatment
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).
Osteoarthritis (OA) of the first carpometacarpal (CMC) joint, or basal joint of the thumb, is a common, painful, and debilitating disease. For patients whose symptoms persist despite conservative therapies and rehabilitation strategies, surgery remains the last-resort treatment.
Allocetra is an immunomodulatory cell-based therapy consisting of allogeneic peripheral blood mononuclear cells that have been modified to be engulfed by macrophages and reprogram them into their homeostatic state.
This study is a single center safety and efficacy assessment trial to assess intra-articular administration of Allocetra in patients suffering from thumb osteoarthritis in the 1st CMC joint (basal thumb joint) who have not responded sufficiently to conventional therapies.
The study is comprised of a safety run-in stage to characterize safety of Allocetra injections at different doses, followed by a placebo-controlled double-blind randomized stage to evaluate the safety and efficacy of Allocetra injection to the basal thumb joint.
Patients will be followed for up to a year following treatment.
2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.
This study's planned enrollment of 46 is below the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Kaplan Medical Center is the lead sponsor of 37 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects eligible for this clinical study must fulfill all of the following:
Exclusion Criteria:
Subjects not eligible for this study include those that have any of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Allocetra - Safety run-in phase
Injection of Allocetra to the 1st CMC joint in the target thumb.
Drug: Allocetra - Randomization phase
Injection of placebo to the 1st CMC joint in the target thumb.
Other: Placebo
Intra-articular injection of Allocetra performed once on Day 1 of the study at different doses.
Intra-articular injection of placebo solution containing all excipients except for the Allocetra cells.
Intra-articular injection of selected dose of Allocetra based on the safety run-in, performed on Day 1 of the study.
Injection-related reactions
Injection-related reactions occurring during study treatment injection, including injection interruption/discontinuation.
Time frame: Day 0 (Treatment visit).
Treatment emergent adverse events
Treatment emergent adverse events following study treatment injection. Safety assessments beyond 4 weeks following injection will focus on events that are at least possibly related to study treatment.
Time frame: Day 0 to 6 months.
Thumb base pain - NRS
Thumb base pain numerical rating scale (NRS; 0-10).
Time frame: Screening day to 12 months.
Hand function - FIHOA
Hand function, assessed by Functional Index for Hand Osteoarthritis (FIHOA; 0-30).
Time frame: Day 0 to 12 months.
Key pinch and grip strength
Key pinch and grip strength - measured with dynamometer.
Time frame: Day 0 to 12 months.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Kaplan Medical Center