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reprioritization
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage 1 | Experimental | Stage 1 will include patients who have been treated with standard PsA therapies, and are insufficiently responsive to treatment in one or more involved joints. |
|
| Stage 2 | Experimental | Stage 2 will include patients with oligoarticular PsA (1-4 joints involved), who have received at least one injection of corticosteroids to the target joint with insufficient response. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allocetra | Drug | Intra-articular injecton of Allocetra into the target joint. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary outcome | Number and severity of AEs, SAEs and injection reactions following treatment | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months, 6 months and 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory outcome- assessment of change from baseline in Psoriasis Area and Severity Index (PASI). | 12 months | |
| Exploratory outcome- assessment of change from baseline in Disease Activity in Psoriatic Arthritis (DAPSA) score. | 12 months |
Inclusion Criteria:
Diagnosed with PsA.
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.
Stage 2 patients:
At least one symptomatic joint following attempt of intra-articular injection of corticosteroids, with insufficient response.
Acceptable blood tests- Complete Blood Count (CBC), electrolytes, adequate renal function, adequate liver function.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Medical Center | Haifa | 3109601 | Israel | |||
| Carmel Medical Center |
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| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
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| Haifa |
| 3436212 |
| Israel |
| Meir Medical Center | Kfar Saba | 4428164 | Israel |
| Tel Aviv Sourasky Medical Center - Ichilov | Tel Aviv | 6423906 | Israel |
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |