Posted by Michael Wonder on 20 Sep 2019
SanBio granted regenerative medicine advanced therapy designation from the U.S. FDA for SB623 for the treatment of chronic neurological motor deficits secondary to traumatic brain injury
19 September 2019 - The SanBio Group today announced that the U.S. FDA has granted regenerative medicine advanced therapy designation for SB623 cell therapy for the treatment of chronic neurological motor deficits secondary to traumatic brain injury.
The designation is based on clinical results of SB623 including the Phase 2 Study of Modified Stem Cells in Traumatic Brain Injury (STEMTRA) trial.
The RMAT designation augments the Sakigake Designation for innovative medical products from the Ministry of Health, Labour, and Welfare of Japan.
