IND application cleared for cell therapy to treat COVID-19-related lung damage
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The FDA has cleared an investigational new drug application for CLBS119 — an autologous CD34+ cell therapy — for repair of COVID-19-induced lung damage, according to a press release from the agent’s manufacturer.
The FDA authorization allows the agent’s manufacturer, Caladrius Biosciences, to begin its clinical trial of patients with severe SARS-CoV-2 infection who had respiratory failure.
“We appreciate the FDA’s expeditious review and approval of the IND for CLBS119,” Douglas W. Losordo, MD, FACC, FAHA, chief medical officer at Caladrius, said in the release.
Losordo explained that most COVID-related therapies target the virus itself or the severe inflammation that accompanies the acute phase of the disease. His company’s treatment will target the longer-term damage associated with COVID-19.
The clinical trial will evaluate the efficacy of CD34+ cell therapy for restoring lung function of patients with COVID-19 who required ventilatory support due to respiratory failure.
“CLBS119 offers the potential to repair the lung damage caused by COVID-19 and to address a serious unmet need for patients,” Losordo said. “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.”