CellProthera and BioCardia Collaborate on Phase 2 Trial of ProtheraCytes to Treat AMI

July 8, 2024—France-based CellProthera and BioCardia, Inc., which is headquartered in California, announced findings from the collaborative phase 2 trial of CellProthera’s ProtheraCytes for the treatment of acute myocardial infarction (AMI). Additionally, the companies noted they plan to continue the collaboration into phase 3.

CellProthera is a developer of cell-based therapies to repair ischemic tissues. BioCardia develops cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases. In 2023, the companies announced an extension of their long-term partnership related to continuing investigations.

According to the companies’ press release, the CellProthera-led phase 1/2b EXCELLENT trial evaluated the feasibility of transendocardial administration of ProtheraCytes when delivered in combination with the standard of care for AMI. The ProtheraCytes, which are autologous, expanded CD34+ stem cells, were injected using BioCardia’s Helix percutaneous catheter delivery system. ProtheraCytes are registered as an Advanced Therapy Medicinal Product by the European Medicines Agency.

The results suggested an effective solution for preventing heart failure progression in the patients at high risk after a heart attack, stated the companies.

The companies further reported that the ProtheraCytes were well tolerated with no unexpected serious adverse events reported. The treatment was associated with improvements in multiple efficacy endpoints, including a significant improvement of the viability of segments from baseline to 6 months, a consistent positive trend of improvement of left ventricle volumes at 6 months, and a faster decrease in NT-proBNP.

Matthieu de Kalbermatten, CEO, CellProthera, and Peter Altman, PhD, President and CEO of BioCardia, addressed the findings and the companies’ collaboration in the press release.

“The promising results of the study confirm the potential of our therapy to provide an effective one-off solution to prevent heart failure progression in AMI patients,” commented Kalbermatten. “We are actively planning for what comes next and we have valued the responsiveness of the BioCardia team throughout the EXCELLENT trial in supporting training, attending clinical cases, and providing delivery systems. We have great learnings today that will enhance our efforts in what comes next, together.”

Altman added, “The EXCELLENT trial has meaningful results for patient benefit using an approach that we feel makes enormous sense for locally administered, high effective dosage of autologous CD34+ cells for these patients. I am personally impressed by their approach. It has been an honor to support CellProthera and we look forward to collaborating in the study to follow. We are ready for what comes next with enhancements to our delivery capabilities.”