Amniotics today announced that several batches of PulmoStem have been certified by the company’s Qualified Person (QP) and that clinical sites in the UK and Sweden are set to start the enrollment of subjects in the first-in-human Phase I/II study of hospitalized COVID-19 patients.
“During the summer we have worked intensely on completing the preparations at the trial sites and preparing for the release of PulmoStem™ for our first clinical trial. We are therefore very pleased to announce that Amniotics’ QP has released several batches of PulmoStem™ to the clinical sites, which means that we are set for the start of the trial. We expect to have the first patients enrolled shortly and to be able to present results from the study in the second half of 2023,” says Kåre Engkilde, CEO at Amniotics.
The study has previously been approved by the regulatory authorities in the UK, the Medicines & Healthcare products Regulatory Agency (MHRA) and in Sweden, the Medical Products Agency (MPA).
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