Enlivex Therapeutics Ltd.
This is a multicenter, randomized, double-blind, placebo-controlled, Phase IIb study to evaluate intra-articular (IA) injections of Allocetra in participants with moderate-to-severe age related symptomatic primary knee osteoarthritis (OA).
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. The main goal of this Phase IIb clinical trial is to evaluate the efficacy of intra-…
Inclusion Criteria: Participants must meet all of the inclusion criteria listed below to be eligible for the study: 1. Age 64 years or above. 2. Diagnosis of primary femorotibial knee OA. 3. Radiographic evidence of knee OA defined as Kellgren-Lawrence (KL) grade 2 or 3 in the index knee. 4. Participants who are intolerant to, or have failed to adequately respond to at least 2 OA therapies. 5. Index knee pain assessed during the screening period and following wash-out of pain medications. 6. Willingness to abstain from prohibited medications/treatments during the trial. 7. Women who are post…
Allocetra is a cell-based therapy consisting of non-HLA-matched allogeneic peripheral blood mononuclear cells, induced to an apoptotic stable state.
The control used in this study will be placebo. Placebo solution containing all excipients except for the Allocetra cells.