The Biomedical Advanced Research and Development Authority (BARDA; DC, USA) has designated MultiStem® as a ‘Highly Relevant’ cell therapy for acute respiratory distress syndrome (ARDS). ARDS is the primary cause of fatality following COVID-19 infection, resulting in a significantly decreased oxygen uptake, but currently has limitedly effective treatments.
MultiStem, a bone marrow-derived stem cell product that contains multipotent adult progenitor cells known as MAPC, was developed by Athersys Inc. (OH, USA) for the treatment of ARDS prior to the COVID-19 outbreak. Having already obtained Fast Track status from the US FDA (MD, USA), the new designation from BARDA will be an encouraging sign for the company and therapy.
“Throughout all of 2019, we made important progress in our key clinical programs in stroke and in other areas, as evidenced by the highly promising clinical results from our ARDS program. Those results led to the subsequent Fast Track designation from the FDA,” commented Gil Van Bokkelen, Chairman and Chief Executive Officer of Athersys.
ARDS can be caused by a number of different conditions, including a range of pathogens, and while various techniques are currently being investigated to mitigate the damage that is caused before it becomes too severe or to regenerate the damage to the lungs, many are still in the early stages of development. There are currently no effective treatments for ARDS, meaning the management of the condition has been largely reduced to ventilating the patients.
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“The importance of this program has been reinforced by the recent COVID-19 outbreak, where many patients have subsequently become critically ill with ARDS, which a recent World Health Organization (Geneva, Switzerland) analysis has confirmed is the primary cause of death for these patients. This often-fatal syndrome can be induced by a range of pathogens, including COVID-19, SARS, MERS and virulent influenza,” continued Van Bokkelen.
“Other than placing patients on a ventilator, there is no effective treatment for ARDS. In January, in the early stages of the COVID-19 outbreak, as part of the US Government's COVID-19 CoronaWatch program, we were approached by BARDA in its leadership role focused on expediting diagnostics, vaccines, antivirals and therapeutic treatments for these patients. After undergoing multiple reviews, we are pleased to announce that MultiStem was designated as a ‘Highly Relevant’ therapeutic for COVID-19 by BARDA. We now are working to expedite the further advancement of the program, which has also shown relevance to certain other areas of interest for BARDA.”
The production of MultiStem involves extracting bone marrow cells from healthy individuals and expanding them to produce a stem cell bank with millions of doses. These cells can be transplanted without the need for tissue-matching and are being investigated for their ability to heal and regenerate. It has been shown that the MultiStem product releases a collection of cytokines before being cleared from the body. One method of action is their ability to reduce consistent inflammation, which could be a major route to preventing deterioration of the lungs’ condition.
Athersys are currently preparing for a Phase III clinical trial that they hope will confirm the effectiveness of MultiStem on ARDS, allowing the roll out of the therapy to the wider population.
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