https://bio.nikkeibp.co.jp/atcl/news/p1/25/11/17/13973/

Nipro Announces Application for Formal Approval of Autologous MSC “Stemirac Injection” for Spinal Cord Injury Following Post-Marketing Surveillance

Nipro has submitted an application for formal approval of “Stemirac Injection” (generic name: human [autologous] bone marrow-derived mesenchymal stem cells), an autologous bone marrow mesenchymal stem cell (MSC) for spinal cord injury, which it co-developed with Sapporo Medical University and received conditional and time-limited approval on December 28, 2018. According to the company’s press release, a post-marketing approval conditional evaluation was conducted, and “efficacy and safety were verified within seven years of the approval deadline.