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RECRUITINGPhase 1INTERVENTIONAL

Evaluation of Allocetra by Intra-articular Injection for the Treatment of Psoriatic Arthritis

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: 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 for at least 3 months prior to 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- Complete Blood Count (CBC), electrolytes, adequate renal function, adequate liver function. Who Should NOT Join This Trial: 1. Prior intra-articular injection to the target joint of steroids, hyaluronate or other drugs within 3 months prior to treatment. 2. Any significant injury to the target joint within the 6 months prior to treatment, or any surgery to the target joint within the 12 months prior to treatment. 3. Findings of acute fractures, severe loss of bone density, chondrocalcinosis and/or severe bone or joint deformity in the target joint. 4. Evidence of active local infection in the target joint. 5. Concomitant rheumatic, inflammatory or autoimmune conditions (where your immune system attacks your own body) other than PsA. 6. Other limb pain of unknown etiology. 7. Any evidence of clinically significant active infection. 8. Major medical condition as detailed in the protocol. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 for at least 3 months prior to 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- Complete Blood Count (CBC), electrolytes, adequate renal function, adequate liver function. Exclusion Criteria: 1. Prior intra-articular injection to the target joint of steroids, hyaluronate or other drugs within 3 months prior to treatment. 2. Any significant injury to the target joint within the 6 months prior to treatment, or any surgery to the target joint within the 12 months prior to treatment. 3. Findings of acute fractures, severe loss of bone density, chondrocalcinosis and/or severe bone or joint deformity in the target joint. 4. Evidence of active local infection in the target joint. 5. Concomitant rheumatic, inflammatory or autoimmune disease other than PsA. 6. Other limb pain of unknown etiology. 7. Any evidence of clinically significant active infection. 8. Major medical condition as detailed in the protocol.

Treatments Being Tested

DRUG

Allocetra

Intra-articular injecton of Allocetra into the target joint.

Locations (4)

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