Henry Ford Health Enrolls First Patient In BioCardia’s Phase 3 CardiAMP HF II Trial Evaluating Cell Therapy For Heart Failure

BioCardia, Inc., a global leader in the development of cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, announced that the first patient has been enrolled at Henry Ford Health in its ongoing Phase 3 CardiAMP® HF II clinical trial. This pivotal study is designed to evaluate the safety and efficacy of the company’s CardiAMP cell therapy in treating patients suffering from ischemic heart failure with reduced ejection fraction (HFrEF).

The CardiAMP HF II trial follows BioCardia’s earlier CardiAMP-HF study, which was groundbreaking for its exploration of autologous cell therapy in heart failure. Although the primary endpoint in the initial study was not achieved, significant clinical benefits were observed in patients with elevated biomarkers of cardiac stress. These findings have helped shape the ongoing Phase 3 trial, which aims to validate and expand upon those promising outcomes.

Dr. Gerald Koenig, M.D., Director of the Cardiac Catheterization Laboratory at Henry Ford West Bloomfield Hospital, Director of Clinical Research in the Cardiac Catheterization Laboratory at Henry Ford Health System, and Principal Investigator of the CardiAMP HF II trial, highlighted the importance of this next phase of research. “The CardiAMP-HF trial, in which Henry Ford Health participated, was groundbreaking for the field of heart failure. Although the primary endpoint was not met, the study showed impressive results with an autologous cell therapy in patients with HFrEF, particularly those with elevated biomarkers of heart stress. Our team is actively offering patients the opportunity to participate in this important confirmatory study intended to enhance microvascular function and improve patient outcomes, including quality of life.”

The CardiAMP HF II study aims to confirm the benefits observed in previous research, including reduced mortality and major adverse cardiac events, alongside improved quality of life for patients with advanced heart failure. By using a patient’s own bone marrow cells, the CardiAMP therapy is designed to stimulate natural repair mechanisms, restore cardiac function, and slow disease progression.

Peter Altman, PhD, CEO of BioCardia, emphasized the significance of the company’s collaboration with Henry Ford Health and its broader potential impact. “We greatly value our collaboration with Dr. Koenig and the world-class Henry Ford Health team in the CardiAMP HF II Trial,” said Dr. Altman. “Between the U.S. and the EU, there are roughly 2 million ischemic HFrEF patients with NYHA Class II and III symptoms. Many of these patients have a prognosis worse than many cancers and few remaining options. 

This places a terrible burden on patients, their families, and the healthcare system. We are excited by the CardiAMP HF results showing that our cell therapy system reduced both mortality and major adverse cardiac events, improved quality of life, and showed positive impacts to other study endpoints in patients with HFrEF. These results suggest that our investigational cell therapy could address important clinical needs.”

BioCardia’s CardiAMP program represents one of the most advanced autologous cell therapy platforms targeting ischemic heart failure. By integrating a proprietary diagnostic system to identify ideal candidates and deliver personalized treatment, the therapy seeks to redefine the standard of care for patients with limited options. The company’s ongoing commitment to clinical innovation continues to strengthen its leadership in regenerative cardiovascular medicine, offering renewed hope to millions affected by severe heart failure worldwide.