NCT06459063

Intra-articular Allocetra in Osteoarthritis of the 1st Carpo-metacarpal Joint

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Kaplan Medical Center · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Osteoarthritis Thumb

Interventions

Type	Name	Description
DRUG	Allocetra - Safety run-in phase	Intra-articular injection of Allocetra performed once on Day 1 of the study at different doses.
OTHER	Placebo	Intra-articular injection of placebo solution containing all excipients except for the Allocetra cells.
DRUG	Allocetra - Randomization phase	Intra-articular injection of selected dose of Allocetra based on the safety run-in, performed on Day 1 of the study.

Timeline

• Start date: 2024-06-10
• Primary completion: 2026-09-01
• Completion: 2027-01-01
• First posted: 2024-06-14
• Last updated: 2026-04-13

Locations

1 site across 1 country: Israel