The clinical study is evaluating the lung-specific stem cell therapy PulmoStem™ in hospitalized patients with severe respiratory infections, including COVID-19, Influenza A, and other causes.
The primary objective of the study is to evaluate the safety and tolerability of intravenous (IV) dosing of PulmoStem™ in patients with severe lower respiratory tract infections, including COVID-19, Influenza A, Metapneumovirus and Respiratory Syncytial Virus (RSV). The study also includes secondary and explorative endpoints related to lung regeneration indicators, biomarkers of inflammatory response and other clinical efficacy outcome measures.
“The initiation of this clinical trial is a major milestone for Amniotics. PulmoStem™ provides a novel approach for the treatment of severe and potentially fatal lung diseases, and our aim is to help patients that are in need of better treatments”, says Marcus Larsson, CEO at Amniotics
PulmoStem™ is a lung-specific stem cell product, derived from full-term amniotic fluid. PulmoStem™ is expected to be efficacious in various acute and chronic diseases of the lung through modulation of the immune response and anti-fibrotic capabilities. The first-in-human clinical study with PulmoStem™, is targeting hospitalized patients suffering from severe lower respiratory tract infections due to COVID-19, Influenza A, Metapneumovirus, Respiratory Syncytial Virus (RSV) and other causes, which can lead to Acute Respiratory Distress Syndrome (ARDS). PulmoStem™ is also being investigated for lung transplantation treatment and chronic lung-disease e.g. Idiopathic Pulmonary Fibrosis (IPF).