This is a pilot study to assess safety and possible efficacy of Allocetra-OTS in end-stage knee osteoarthritis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
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.
Kaplan Medical Center
Rehovot, Israel
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: * Injection-related reactions occurring during Allocetra-OTS injection, including injection interruption/discontinuation. * Treatment-emergent adverse events following Allocetra-OTS injection. * Treatment-emergent serious adverse events. * Adverse events or serious adverse events related to the use of Allocetra-OTS as an intraarticular injection material. * Safety assessments beyond 1 month following injection will focus on events that are at least possibly related to Allocetra-OTS treatment.
Time frame: 6 months
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').
Time frame: 6 months
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.
Time frame: 6 month
SF-36 questionnaire response change along study period
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SF-36 questionnaire response change along study period (questionnaires aimed at assessing quality of life,).
Time frame: 6 month