STEM CELL THERAPY: Update on Patients Treated with PLX cells for Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19

On May 14, 2020, Pluristem Therapeutics Inc. published follow-up data on patients treated under their compassionate use program. These patients were all being treated for with Acute Respiratory Distress Syndrome (ARDS) associated with the SARS-CoV-2 virus, and in intensive care units requiring mechanical ventilation.

As of the publication date, 18 patients have been treated with PLX cells, allogeneic mesenchymal-like cells derived from human placentas after the delivery of full-term healthy babies. The patients treated include one patient in the United States. This patient received the treatment as part of the FDA Single Patient Expanded Access Program, a compassionate use program under the U.S. Coronavirus Treatment Acceleration Program, designed to fast-track the availability of new treatments for COVID-19. The treatment was administered at Holy Name Medical Center in New Jersey, which has been a site for Pluristem’s Phase III critical limb ischemia (CLI) study.

The follow-up data looks at the 8 patients that were treated 28 days ago. Of those 8 patients, survival is 87.5% (7 patients). 75% no longer require mechanical ventilation (6 patients). 62.5% have been discharged alive from the hospital (5 patients).

The PLX cells have an immunomodulary 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.

On May 8th, Pluristem announced that the U.S. Food and Drug Administration (FDA) has approved 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. 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. While the primary outcome is ventilator-free days within a 28-day period, the patients will follow up at regular intervals for up to a year in order to demonstrate long-term safety and survival.

To learn more about stem cells and cord blood banking, request an information packet.