Posted by Michael Wonder on 22 Dec 2017
Mesoblast receives FDA regenerative medicine advanced therapy designation for its cell therapy in heart failure patients with left ventricular assist devices
21 December 2017 - Mesoblast today announced that the United States FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation for its novel mesenchymal precursor cell (MPC) therapy in the treatment of heart failure patients with left ventricular systolic dysfunction and left ventricular assist devices.
The RMAT designation under the 21st Century Cures Act aims to expedite the development of regenerative medicine therapies intended for the treatment of serious diseases and life-threatening conditions.
The basis of this RMAT designation grant came from the completed study data set of a 30-patient randomised, blinded, placebo-controlled pilot trial of Mesoblast’s MPCs at a dose of 25 million cells in heart failure patients with LVADs, and related analyses.
