Home Topics Lung Infection

Mesoblast announced data from a phase 2/3 trial evaluating remestemcel-L, an allogeneic mesenchymal stem cell product candidate, in ventilator-dependent COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS).

Remestemcel-L consists of culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor. It is believed to work by down-regulating the production of proinflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.

The randomized, placebo-controlled trial is being conducted at Mount Sinai hospital in New York City. Patients were treated with a variety of experimental agents prior to receiving remestemcel-L. Findings from the study showed 83% survival in ventilator-dependent COVID-19 patients with moderate/severe ARDS (n=10/12) following 2 intravenous infusions of remestemcel-L within the first 5 days; 75% of patients (n=9/12) were able to successfully come off ventilator support at a median of 10 days. There have been 7 patients discharged from the hospital as of now.

Mesoblast Chief Executive Dr. Silviu Itescu stated: The remarkable clinical outcomes in these critically ill patients continue to underscore the potential benefits of remestemcel-L as an anti-inflammatory agent in cytokine release syndromes associated with high mortality, including acute graft versus host disease and COVID-19 ARDS. We intend to rapidly complete the randomized, placebo-controlled phase 2/3 trial in COVID-19 ARDS patients to rigorously confirm that remestemcel-L improves survival in these critically ill patients.

Additionally, the Food and Drug Administration recently accepted for Priority Review the Biologics License Application of remestemcel-L for the treatment of steroid-refractory acute graft vs host disease. The Company expects to launch remestemcel-L in 2020 if approved.

For more information mesoblast.com.

This article originally appeared on MPR

Please login or register first to view this content.

LoginRegister

Next post in Lung InfectionClose

Continue reading here:
Remestemcel-L Looks Promising for COVID-19 With Moderate to Severe ARDS - Pulmonology Advisor