Longeveron Expands Enrollment Criteria for Trial Evaluating Lomecel-B Infusion ARDS due to COVID-19

Longeveron announced enrollment criteria for its Phase 1 Acute Respiratory Distress Syndrome (ARDS) RECOVER trial has been expanded to include mild ARDS, in addition to moderate and severe ARDS. Previously, only ARDS patients intubated with an endotracheal tube for positive pressure ventilation were eligible. The protocol amendment allows for the inclusion of milder cases of ARDS patients who present with the need for supplemental oxygen via high flow nasal cannula, partial or nonrebreathing mask, or non-invasive positive pressure mask.

The RECOVER Trial is a double-blind, randomized, placebo-controlled study designed to evaluate the safety and efficacy of up to 3 intravenous administrations of either Lomecel-B (allogeneic bone marrow-derived medicinal signaling cells) or placebo in COVID-19 or Influenza-infected ARDS patients. The primary measures of efficacy are functional lung recovery, recovery from infection, inflammatory status, immune status, and lung imaging.

“The goal here is to reduce the inflammatory response and to either prevent the need for mechanical support, or to allow these individuals to come off of the ventilator and leave the ICU,” said Joe G. N. "Skip" Garcia, MD, a pulmonologist and professor of medicine at the University of Arizona College of Medicine.

ARDS resulting from COVID-19 or Influenza is driven by severe inflammation, called a cytokine storm. This can lead to accumulation of fluid in the lungs and severe tissue damage, and ultimately decreased ability to oxygenate the blood. The most severe cases lead to respiratory failure and the high mortality rate from COVID-19. Longeveron’s Lomecel-B has the potential to reduce the cytokine storm involved in ARDS and thus the possibility to improve clinical outcomes in COVID-19 patients.