Benzinga | Oct 7, 2021 08:07AM EDT

BioCardia Announces First Cross-Over Patient Treated In CardiAMP Cell Therapy Heart Failure Trial

BioCardia(r), Inc. (NASDAQ:BCDA) a company focused on developing cellular and cell derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the treatment of the first cross-over patient in the ongoing Phase III Pivotal CardiAMP(r) Cell Therapy in Heart Failure Trial for the treatment of ischemic heart failure. A cross-over patient is one who was previously in the control group of the study, has completed follow-up, and elects to receive therapy.

The patient was treated with the CardiAMP autologous bone marrow cell therapy procedure at Stanford University, by interventional cardiologist Dr. David Lee, in the trial led by Principal Investigator, cardiologist Dr. Phillip Yang. The cell therapy procedure is a minimally invasive catheter-based approach, which allowed the patient to be discharged from the hospital the morning after the study procedure per the protocol.

"Patients are the true heroes in the CardiAMP Cell Therapy trials, and by allowing them the cross-over option, all patients have the opportunity to receive the investigational therapy" said BioCardia CEO Peter Altman, Ph.D. "We are honored to collaborate with the world class Stanford cardiologists who have made a significant commitment of their time and energies to the ongoing study of the CardiAMP autologous cell therapy for patients with heart failure. With their help and that of their colleagues at hospital centers across the United States, we are working to complete the current trial with the best safety profile and patient care as soon as possible."

A protocol amendment approved by the FDA allows patients in the trial who were initially randomly assigned to the control arm and did not receive therapy to elect to cross-over and receive the investigational autologous CardiAMP Cell Therapy after completing the two-year follow-up. The approval of the study's cross-over arm was based in part on the study's Data Safety Monitoring Board's formal assessments during the trial. The amendment also included provisions for following cross-over patients for a period of one additional year under the clinical protocol.