This is an open label study to evaluate the safety and initial efficacy of intra-articular administration of Allocetra in patients with Psoriatic Arthritis (PsA).
Psoriatic Arthritis (PsA) is a prevalent chronic inflammatory disease that mainly affects the synovial joints, and leads to inflammatory arthritis, in addition to skin manifestations. If left untreated, inflammatory arthritis leads to joint damage and deformities. 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. As macrophages play a crucial role in the initiation of PsA immunopathogenesis, they are considered an emerging target for PsA treatment. This study will assess the safety of Allocetra injection to the joint (knee, elbow or ankle) in patients with PsA, and evaluate the preliminary responses to treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Intra-articular injecton of Allocetra into the target joint.
Rambam Medical Center
Haifa, Israel
Carmel Medical Center
Haifa, Israel
Meir Medical Center
Kfar Saba, Israel
Tel Aviv Sourasky Medical Center - Ichilov
Tel Aviv, Israel
Primary outcome
Number and severity of AEs, SAEs and injection reactions following treatment
Time frame: 12 months
Patient reported pain Numeric Rating Scale (NRS) in the target joint.
Evaluation of change from baseline in patient reported pain Numeric Rating Scale (NRS) in the target joint.
Time frame: 3 months, 6 months and 12 months.
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