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A regenerative medicine company from Melbourne was in the limelight last week after its treatment addressing the leading cause of death from COVID-19 infections led to a "remarkable" reduction in mortality amongst a small group of patients in New York.
Mesoblast's (ASX: MSB) stem cell treatment from bone marrow aspirate allowed nine (75 per cent) out of 12 patients suffering from acute respiratory distress syndrome (ARDS) to come off ventilators, compared to an average rate of 9 per cent for hospitals in the city.
Now the company is taking its trials of the stem cell therapy remestemcel-L up a notch after announcing a a Phase 2/3 randomised, placebo-controlled trial across more than 20 medical centres in the US.
Enrolments have begun with plans to bring 300 patients into the trial within three to four months, although interim analyses are planned which could result in stopping the trial early for efficacy or futility.
"There are limited treatment options for ventilator-dependent patients with acute respiratory distress syndrome, the principal cause of mortality in COVID-19 infection," says Mesoblast chief executive and founder Silviu Itescu.
"Based on the encouraging initial results of remestemcel-L treatment under emergency compassionate use in New York, there is an urgent need to execute this robust randomised placebo-controlled trial in order to definitively determine whether this cell therapy can reduce the mortality of patients with COVID-19 ARDS on ventilators."
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Patients in the trial will receive either two intravenous infusions of remestemcel-L within five days or placebo on top of maximal care. Two key outcomes to be measured will be rates of all-cause mortality and the number of days off ventilator support.
"The promising initial results using remestemcel-L in the emergency compassionate use protocol create an imperative for an appropriately-sized definitive randomised controlled trial," says Mesoblast chief medical officer Dr Fred Grossman.
"We believe the central mechanism by which remestemcel-L modulates the inflammatory process provides a compelling rationale between these results in COVID-19 ARDS and other inflammatory conditions where the cell therapy has shown clinical benefits."
The trial will be conducted in collaboration with the Cardiothoracic Surgical Trials Network, which was established by the United States National Institutes of Health's National Heart, Lung and Blood Institute as a flexible platform for conducting collaborative trials.
Mesoblast holds an Investigational New Drug (IND) application cleared by the United States Food and Drug Administration (FDA) for use of remestemcel-L in the treatment of patients with COVID-19 ARDS, and will provide investigational product of remestemcel-L for the trial."
Related story: Mesoblast treatment achieves "remarkable" results for critical Covid-19 patients
Updated at 11:16am AEST on 30 April 2020.
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