Basking Ridge-based Caladrius Biosciences, a clinical-stage biopharmaceutical company that focuses on the development of cellular therapies designed to reverse, not manage disease, recently said the U.S. Food and Drug Administration authorized its investigational drug application for the study of CLBS119, a CD34+ cell therapy for repair of COVID-19 induced lung damage.
The study will target patients with severe SARS-CoV-2 infection that required ventilatory support due to respiratory failure.
“We appreciate the FDA’s expeditious review and approval of the IND for CLBS119. Early reports indicate that many of the survivors of COVID-19 that required ventilatory support remain debilitated due to the lung injury sustained as a result of the virus. COVID-19 appears to damage the vasculature of the lungs and repair of that vasculature will be necessary for patients to achieve a full recovery,” said Chief Medical Officer Dr. Douglas Losordo in a statement.
Losordo said that although many therapies are targeting the SARS-CoV-2 virus itself, or the reduction of severe inflammation during the acute phase of the illness, no therapy has been shown to repair COVID-19 induced lung damage.
“CLBS119,” said Losordo, “offers the potential to repair the lung damage caused by COVID-19 and to address a serious unmet need for patients. In previous clinical trials and preclinical models, CD34+ cells consistently have shown evidence of vascular repair in multiple organs including models of severe lung inflammation. In the proposed trial, Caladrius plans to evaluate whether CD34+ cells can be used to effectively restore lung function in patients with severe SARS-CoV-2 infection that required ventilatory support due to respiratory failure.”