On May 8th, 2020, Pluristem announced that the U.S. Food and Drug Administration (FDA) has approved their PLX cell therapy as an Investigational New Drug (IND) for a Phase II clinical trial in the treatment of severe COVID-19 cases complicated by Acute Respiratory Distress Syndrome (ARDS). The study will be a randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of intramuscular injections of PLX-PAD cells for the treatment of severe COVID-19.
The patients will be treated with PLX cells, allogeneic mesenchymal-like cells derived from human placentas after the delivery of full-term healthy babies. The PLX cells have an immunomodulatory effect which help prevent or reverse an overactivation of the immune system. This overactivation, sometimes referred to as the ‘cytokine storm’ causes a hyperinflammatory state that is believed to be a source of mortality in COVID-19 and other respiratory illnesses. It is intended to treat 140 adult patients in multiple locations throughout the United States that are intubated and mechanically ventilated and are suffering from respiratory failure and ARDS due to COVID-19, with the primary outcome being ventilator-free days within a 28-day period. In addition, in August 2020, the FDA cleared PLX cell therapy for in their Expanded Access Program, which allows patients who are not eligible for clinical trials to access it. This is a multi-center trial that is still actively recruiting patients, including at Maimonides Medical Center and Mercy Medical Center in NYC.