Australian regenerative medicine company Mesoblast (ASX: MSB) is moving quickly on plans to repurpose its stem cell treatment to help fight Covid-19, securing a multi-center Phase
2/3 trial in the US.
Within days of gaining Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) for its product remestemcel-L, Mesoblast has announced a partnership with the Cardiothoracic Surgical Trials Network (CTSN) for a trial with 240 patients.
The aim of the randomised, placebo-controlled trial is to test the treatment's impact on acute respiratory distress syndrome (ARDS) caused by Covid-19.
Using bone marrow aspirate from healthy donors, Mesoblast's proprietary technology is currently used to treat a condition called acute graft versus host disease (aGVHD), which many suffer after receiving a bone marrow transplant (BMT).
"Remestemcel-L has demonstrated safety, efficacy and significant survival benefit in aGVHD where inflammation is at the core, similar to ARDS from Covid-19," says Mesoblast chief medical officer Dr Fred Grossman.
Grossman notes the mortality rate in moderate to severe ARDS due to Covid-19 can be as high as 80 per cent.
"The mechanism of action of remestemcel-L demonstrated in aGVHD supports the evaluation of remestemcel-L to safely tame a similar cytokine storm in the lungs that leads to the high mortality in patients with COVID-19."
Mesoblast chief executive Dr Silviu Itescu is upbeat about the arrangement with CTSN, which was established by the United States National Institutes of Health's National Heart, Lung and Blood Institute (NHLBI) as a flexible platform for conducting collaborative trials.
"This significant public-private partnership is a prime example of how the combined resources of industry and government can be leveraged to evaluate in a most efficient and rigorous manner the potential of innovative therapies to make a meaningful difference to patient outcomes," says Itescu.
CTSN chairman Dr A. Marc Gillinov says the network is excited to work with Mesoblast to make a "real impact on the high mortality associated with Covid-19".
"This randomised controlled trial is in line with our mandate to rigorously evaluate novel therapies for public health imperatives," says Gillinov.
"The Covid-19 pandemic has resulted in very large numbers of people suffering with ARDS requiring ventilation in hospital intensive care units, with dismal outcomes, placing an enormous burden on the United States health system," adds Dr Annetine Gelijns, the Edmond A. Guggenheim Professor of Health Policy at the Icahn School of Medicine at Mount Sinai.
"We are committed to evaluating whether Mesoblast's mesenchymal stem cell product candidate for ARDS has the potential to make an impact on this unprecedented health crisis."
Updated at 9:34am AEST on 9 April 2020.
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