Late-stage study of Mesoblast cell therapy in COVID-19 to continue as is

The independent Data Safety Monitoring Board has completed its first interim analysis of data from a Phase 3 clinical trial evaluating Mesoblast Limited’s (MESO -0.3%) remestemcel-L, an allogeneic mesenchymal stem cell product derived from bone marrow, in COVID-19 patients with moderate-to-severe acute respiratory distress syndrome (ARDS).

Based on preliminary results from 30% of targeted enrollment, the Board recommends that the study continue unchanged.

A total of three interim analyses for stopping accrual early for efficacy or futility will be done (30%, 45% and 60% of total target of randomized patients). Enrollment should be completed in Q4.

The primary endpoint is all-cause mortality within 30 days of randomization. A key secondary endpoint is days alive off mechanical ventilation within 60 days of randomization.

According to the company, remestemcel-L is believed to have immunomodulatory properties to counteract the cytokine storms that are implicated in various inflammatory conditions by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.

https://seekingalpha.com/news/3611755-late-stage-study-of-mesoblast-cell-therapy-in-covidminus-19-to-continue-is