15 July 2019 - Caladrius Biosciences announced today that the EMA has granted Advanced Therapy Medicinal Product classification to the Company’s CD34+ cell therapy product, CLBS12, for the treatment of critical limb ischaemia. 

Advanced therapy medicinal products are defined as medical treatments that are based on genes or cells and are intended as long-term or permanent therapeutic solutions to acute or chronic human diseases at a genetic, cellular or tissue level. 

CLBS12 has previously been awarded a SAKIGAKE designation in Japan, a status which makes the product eligible for early conditional approval based on the on-going clinical trial in that country.

Read Caladrius Biosciences press release