Allocetra™ intra-articular injection for the treatment of psoriatic arthritis

Condition

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.

This study will assess the safety of Allocetra™ injection to the joint (knee, elbow or ankle) and evaluate the preliminary responses to treatment, in patients with PsA who have insufficient responses to conventional therapies.

Assessments

• Reactions following treatment
• Change in target joint pain and inflammatory arthritis

Inclusion and Exclusion Criteria

Inclusion Criteria:

1. Diagnosed with PsA.
2. Stage 1 patients: At least one joint resistant to standard PsA treatments and on a stable dose of approved PsA treatment.
3. Stage 2 patients: At least one symptomatic joint following attempt of intra-articular injection of corticosteroids, with insufficient response.
4. Acceptable blood tests as defined in the protocol.

Exclusion Criteria:

1. Any other disorder in the target joint: Recent prior intra-articular injection of steroids, hyaluronate or other drugs, significant recent injury or surgery, acute fractures, severe loss of bone density, chondrocalcinosis and/or severe bone or joint deformity, active local infection in the target joint.
2. Other limb pain of unknown etiology.
3. Concomitant rheumatic, inflammatory or autoimmune disease other than PsA, active infection or major medical condition as detailed in the protocol.