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Athersys and University Hospitals Cleveland Medical Center (UH Cleveland) have initiated the first clinical site for the MACOVIA trial of MultiStem Cell Therapy to treat Covid-19.
The company received US Food and Drug Administration (FDA) authorisation on 13 April to conduct the MACOVIA trial. UH Cleveland is the first site for the trial and is set to screen participants.
Intended for the treatment of acute respiratory distress syndrome (ARDS) caused by Covid-19, the randomised, double-blind, placebo-controlled study will involve around 400 participants at pulmonary critical care centres across the US.
The multidimensional therapeutic effect of MultiStem Cell Therapy is expected to allow its use to treat ARDS related to different causes, including Covid-19.
MACOVIA will assess the safety and efficacy of MultiStem therapy in patients with moderate to severe ARDS associated with Covid-19.
The primary efficacy endpoint is the number of ventilator-free days until day 28 when compared to placebo, while the secondary objectives include clinical parameters, pulmonary function, all-cause mortality, tolerability, and quality of life.
Athersys Regenerative Medicine vice-president and Cardiopulmonary Programs head Dr Anthony Ting said: “Progressing from an FDA authorisation to a site activation in just a few weeks is a tremendous achievement.
“Based on our prior clinical results, we are optimistic that MultiStem may be able to provide meaningful therapeutic benefits to critically ill patients with Covid-19 induced ARDS.”
The company previously evaluated MultiStem therapy in a Phase I/II MUST-ARDS clinical trial. According to the results, MUST-ARDS met its primary endpoint of tolerability.
Participants treated with MultiStem experienced less mortality, more ventilator-free days, and more intensive care unit (ICU)-free days during the 28-day evaluation period versus placebo.
Athersys is in discussions with the US Biomedical Advanced Research and Development Authority (BARDA) to further develop MultiStem to treat ARDS induced by Covid-19 and other potential pandemics.