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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
46
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.
Kaplan Medical Center
Rehovot, Israel
RECRUITINGInjection-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.
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