Posted by Michael Wonder on 20 Jun 2018
Caladrius receives FDA regenerative medicine advanced therapy designation for CD34+ cell therapy for treating refractory angina
19 June 2018 - Caladrius Biosciences announces today that the U.S. FDA has granted regenerative medicine advanced therapy designation to the Company’s late-stage CD34+ cell therapy program for the treatment of refractory angina.
Caldadrius acquired an exclusive worldwide license to the late-stage CD34+ program from Shire plc in March of this year. The acquisition included the data set and regulatory filings for the CD34+ cell therapy program for the treatment of refractory angina. This includes manufacturing procedures, preclinical (in vivo and in vitro) and Phase 1, Phase 2 and Phase 3 clinical study data of CD34 cell therapy as a treatment for no-option refractory angina, along with the corresponding regulatory filings.
