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| Name | Class |
|---|---|
| Enlivex Therapeutics Ltd. | INDUSTRY |
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This is a pilot study to assess safety and possible efficacy of Allocetra-OTS in end-stage knee osteoarthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allocetra-OTS | Experimental | Two IA dose of Allocetra-OTS cells in suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allocetra-OTS | Drug | Allocetra-OTS is a cell-based therapy consisting of non-HLA-matched allogeneic peripheral blood mononuclear cells, derived from a healthy human donor following a leukapheresis procedure, induced to an apoptotic stable state and suspended in a solution containing DMSO. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent adverse events and Serious adverse events following Allocetra-OTS injection | The safety and tolerability endpoint evaluates the incidence and severity of complications following intraarticular injection of Allocetra-OTS:
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Allocetra-OTS- Pain mitigation as measured by Visual Analog Scale tool. | To assess the efficacy of Allocetra-OTS. Secondary endpoints for efficacy will be measured in terms of: • Pain mitigation as measured by VAS (Visual Analog Scale) tool in a range of 0-10 points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amir Oron, MD | Kaplan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaplan Medical Center | Rehovot | Israel |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) response change along study period | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) response change along study period (questionnaires aimed at assessing arthritis related function ). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score, however there are other methods that have been used to combine scores. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. | 6 month |
| SF-36 questionnaire response change along study period | SF-36 questionnaire response change along study period (questionnaires aimed at assessing quality of life,). | 6 month |
| D012216 |
| Rheumatic Diseases |