ARTICLE | Clinical News

Adult stem cells regulatory update

October 6, 2014 7:00 AM UTC

Mesoblast said partner JRC submitted a regulatory application in Japan for JR-031 to treat graft-versus-host disease (GvHD) in children and adults. JR-031, which consists of allogeneic adult mesenchymal precursor cells (MPCs) used to expand cord blood by up to 40-fold, has Orphan Drug designation in Japan and will undergo Priority Review. If the product is approved, Mesoblast said it would be the first allogeneic cell-based product available in Japan. Mesoblast is eligible for regulatory and sales milestones as well as royalties on sales. ...