Amniotics AB (publ) announced that safety has been established in the first cohort in its Phase Ib clinical study evaluating the lung-specific stem cell therapy PulmoStemTM in hospitalized patients with severe respiratory infections, including COVID-19, RSV, and other causes. The Dose Escalation Committee of the study has concluded that no dose limiting toxicity was found in the one million cells per kilogram cohort, and that dose escalation to two million cells per kilogram may proceed. Patients with Covid-19 as well as Respiratory Syncytial Virus (RSV) were treated in the first cohort.

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 study is an adaptive, dose-escalation trial including hospitalized patients with COVID-19 and other lower respiratory tract infections.

The recruitment is estimated to be completed in First Quarter 2023.