BioCardia announces independent DSMB recommended CardiALLO-HF trial to continue

BioCardia (BCDA) announced that the study’s independent DSMB, which conducted a planned review of the 30-day safety data from the roll-in 20 million cell dosing cohort in the CardiALLO-HF trial, recommended that the study continue as designed. There have been no treatment emergent major adverse cardiac events observed nor has there been any clinical evidence of immune reactions to the allogeneic cells implanted. “We are pleased with the DSMB’s recommendation, an important step forward in advancing this allogeneic off the shelf mesenchymal stromal/stem cell therapy,” said Peter Altman, BioCardia Chief Executive Officer. “Today’s result has potential to be helpful with ongoing discussions around nondilutive funding and partnering opportunities for our MSC platform. Success in this trial can enable future pivotal trial design and funding in the USA, conditional time limited approval with reimbursement in Japan, as well as the advancement of CardiALLO MSC therapy for the likely orphan indications of pediatric and adult congenital heart disease.”