This is a double blind, randomized,multi-center study to evaluate the safety and efficacy of intra-articular administration of Allocetra compared to placebo in patients with symptomatic knee osteoarthritis.
Knee osteoarthritis is a degenerative disease driven by physical breakdown of the joint cartilage, together with a chronic inflammation within the knee space. Over time, many patients will develop worsening pain in the joint and functional impairment, which may ultimately require knee replacement. 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. This Phase 1/2a study is comprised of an open-label safety run-in stage to characterize safety and tolerability of repeated injections of Allocetra to a target knee , followed by a double-blind randomized stage to evaluate the safety and efficacy of Allocetra repeated injections to the target knee compared to placebo, in moderate to severe knee osteoarthritis patients. Patients in both stages will be followed for up to a year following last treatment. the last treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
160
Sanos Clinic Nordjylland
Gandrup, Denmark
Sanos Clinic Herlev
Herlev, Denmark
Sanos Clinic Syddanmark
Vejle, Denmark
Treatment-emergent adverse events and Serious adverse events following Allocetra-OTS injection
Number and severity of adverse events (AEs), serious adverse events (SAEs) and treatment disruptions/ discontinuations throughout the study from Day 0 and up to 6 months following the last injection
Time frame: 7 months following Day 0
Weekly average of knee pain.
Evaluation of change from baseline in weekly average of knee pain as measured using NRS (Numeric Rating Scale ) assessed at 3 months and 6 months from last study treatment. Scores range from 0-10 points, with higher scores indicating greater pain intensity
Time frame: 4 months and 7 months following Day 0.
Change from baseline in WOMAC total score.
Change from baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) total score at 3 months, 6 months, and 12 months from last study treatment administration. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time frame: 4 months, 7 months and 13 months following Day 0.
Change in quality of life- Euro Quality of Life-5-dimension (EQ-5D) questionnaire
Change from baseline in QoL as measured by Euro Quality of Life-5-dimension (EQ-5D) questionnaire at 6 months and at 12 months from last study treatment administration.
Time frame: 4 months, 7 months and 13 months following Day 0.
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