The designation should expedite the review of remestemcel-L, a cellular therapy that has shown promise in treating acute respiratory distress syndrome (ARDS) in COVID-19 patients.
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The trial’s independent Data Safety Monitoring Board (DSMB) recommended that the Phase III study evaluating remestemcel-L continue based on the second interim analysis.
A Phase I clinical trial of remestemcel-L delivered by an endoscope to patients with Crohn’s disease and ulcerative colitis has commenced.
A report has said that with only 152 CMOs able to manufacture the 7,000 cell and gene therapies in the pipeline, production bottlenecks may occur.
US expands access to remestemcel-L for compassionate use in COVID-19 infected children with complications of multisystem inflammatory syndrome.
Researchers announce the first patient has been dosed in a trial testing remestemcel-L, a stem cell therapy, in severe COVID-19 patients on ventilators.