- Mesoblast (MSB) has commenced enrolment for a placebo-controlled trial for its allogeneic mesenchymal stem cell therapy, called remestemcel-L
- The company is trialling whether remestemcel-L improves the survival rate in COVID-19 patients with moderate to severe acute respiratory distress syndrome
- This follows encouraging results from a recent trial conducted in New York that showed an 83 per cent survival rate using remestemcel-L as opposed to a mere 12 per cent in standard care patients
- Mesoblast hopes its novel treatment can add to the currently limited options for ventilator-dependent patients who are facing high mortality rates
- Shares in Mesoblast are up 6.65 per cent and are trading for $3.37 each
Mesoblast (MSB) has begun enrolment for a phase two and three randomised, placebo-controlled trial for its allogeneic mesenchymal stem cell therapy, remestemcel-L.
The company is trialling whether remestemcel-L improves the survival rate in COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS).
More than 20 medical centres across the U.S. will participate in the trial. Enrolment is expected to be complete within three to four months, with interim analyses planned.
The trial will enrol up to 300 ventilator-dependent patients in intensive care units with moderate to severe COVID-19 ARDS, randomised to receive either two intravenous infusions of remestemcel-L within five days or a placebo on top of care.
“There are limited treatment options for ventilator-dependent patients with acute respiratory distress syndrome, the principal cause of mortality in COVID-19 infection,” CEO Dr Silviu Itescu said.
Recruitment of this trial comes off the back of encouraging results from a recent remestemcel-L trial conducted in New York.
A total of 12 patients were treated under an emergency Investigational New Drug (IND) application or expanded access protocol at New York City’s Mt Sinai hospital.
The trial showed that 75 per cent (nine out of 12) of the COVID-19 patients had successfully come off ventilator support at an average of 10 days.
This figure is significantly better than COVID-19 ventilator-dependent patients at a New York hospital network, who received the standard care during March and April, but resulted in just nine per cent (38 out of 445 patients) coming off of ventilator support.
Additionally, Mesoblast’s trial resulted in an 83 per cent survival rate as opposed to 12 per cent in standard care patients.
“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,” Silviu added.
“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,” Chief Medical Officer Dr Fred Grossman said.
The trial will be conducted 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 platform for conducting collaborative trials.
Shares in Mesoblast are up 6.65 per cent and trading for $3.37 each at 10:14 am AEST.